Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China
Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ...
Ausführliche Beschreibung
Autor*in: |
Hu, Chaoying [verfasserIn] Lin, Qingtang [verfasserIn] Liu, Chuan [verfasserIn] Liu, Jacqueline [verfasserIn] Chen, Xiaobao [verfasserIn] Li, Xinxia [verfasserIn] Zhao, Guoguang [verfasserIn] Zhang, Lan [verfasserIn] |
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E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2020 |
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Schlagwörter: |
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Übergeordnetes Werk: |
Enthalten in: Cancer chemotherapy and pharmacology - Berlin : Springer, 1978, 86(2020), 6 vom: 21. Okt., Seite 793-801 |
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Übergeordnetes Werk: |
volume:86 ; year:2020 ; number:6 ; day:21 ; month:10 ; pages:793-801 |
Links: |
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DOI / URN: |
10.1007/s00280-020-04175-0 |
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Katalog-ID: |
SPR041724569 |
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245 | 1 | 0 | |a Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China |
264 | 1 | |c 2020 | |
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520 | |a Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of $ Temodal^{®} $ and spread equally over days 3–5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration ($ C_{max} $), area under the concentration–time curve (AUC) 0-t, AUC 0-∞) fell within the equivalence boundary of 80–125%. Results Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for $ C_{max} $ (91.08%, 106.18%), $ AUC_{0-t} $ (98.62%,102.18%), and $ AUC_{0-∞} $ (98.65%, 102.21%) was well within the 80%–125% range for the 20-mg capsule, as was the $ C_{max} $ (90.49%, 113.32%), $ AUC_{0-t} $ (99.89%, 104.63%) and $ AUC_{0-∞} $ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients. Conclusion It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to $ Temodal^{®} $ capsules of the same strength under fasting conditions. Trial registration https://www.chinadrugtrials.org.cn/index.html, CTR2017 0122. | ||
650 | 4 | |a Temozolomide capsule |7 (dpeaa)DE-He213 | |
650 | 4 | |a Gliomas |7 (dpeaa)DE-He213 | |
650 | 4 | |a Pharmacokinetics |7 (dpeaa)DE-He213 | |
650 | 4 | |a Bioequivalence |7 (dpeaa)DE-He213 | |
700 | 1 | |a Lin, Qingtang |e verfasserin |4 aut | |
700 | 1 | |a Liu, Chuan |e verfasserin |4 aut | |
700 | 1 | |a Liu, Jacqueline |e verfasserin |4 aut | |
700 | 1 | |a Chen, Xiaobao |e verfasserin |4 aut | |
700 | 1 | |a Li, Xinxia |e verfasserin |4 aut | |
700 | 1 | |a Zhao, Guoguang |e verfasserin |4 aut | |
700 | 1 | |a Zhang, Lan |e verfasserin |4 aut | |
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10.1007/s00280-020-04175-0 doi (DE-627)SPR041724569 (SPR)s00280-020-04175-0-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl 44.38 bkl Hu, Chaoying verfasserin aut Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of $ Temodal^{®} $ and spread equally over days 3–5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration ($ C_{max} $), area under the concentration–time curve (AUC) 0-t, AUC 0-∞) fell within the equivalence boundary of 80–125%. Results Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for $ C_{max} $ (91.08%, 106.18%), $ AUC_{0-t} $ (98.62%,102.18%), and $ AUC_{0-∞} $ (98.65%, 102.21%) was well within the 80%–125% range for the 20-mg capsule, as was the $ C_{max} $ (90.49%, 113.32%), $ AUC_{0-t} $ (99.89%, 104.63%) and $ AUC_{0-∞} $ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients. Conclusion It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to $ Temodal^{®} $ capsules of the same strength under fasting conditions. Trial registration https://www.chinadrugtrials.org.cn/index.html, CTR2017 0122. Temozolomide capsule (dpeaa)DE-He213 Gliomas (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Bioequivalence (dpeaa)DE-He213 Lin, Qingtang verfasserin aut Liu, Chuan verfasserin aut Liu, Jacqueline verfasserin aut Chen, Xiaobao verfasserin aut Li, Xinxia verfasserin aut Zhao, Guoguang verfasserin aut Zhang, Lan verfasserin aut Enthalten in Cancer chemotherapy and pharmacology Berlin : Springer, 1978 86(2020), 6 vom: 21. Okt., Seite 793-801 (DE-627)253390435 (DE-600)1458488-8 1432-0843 nnns volume:86 year:2020 number:6 day:21 month:10 pages:793-801 https://dx.doi.org/10.1007/s00280-020-04175-0 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE 44.38 ASE AR 86 2020 6 21 10 793-801 |
spelling |
10.1007/s00280-020-04175-0 doi (DE-627)SPR041724569 (SPR)s00280-020-04175-0-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl 44.38 bkl Hu, Chaoying verfasserin aut Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of $ Temodal^{®} $ and spread equally over days 3–5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration ($ C_{max} $), area under the concentration–time curve (AUC) 0-t, AUC 0-∞) fell within the equivalence boundary of 80–125%. Results Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for $ C_{max} $ (91.08%, 106.18%), $ AUC_{0-t} $ (98.62%,102.18%), and $ AUC_{0-∞} $ (98.65%, 102.21%) was well within the 80%–125% range for the 20-mg capsule, as was the $ C_{max} $ (90.49%, 113.32%), $ AUC_{0-t} $ (99.89%, 104.63%) and $ AUC_{0-∞} $ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients. Conclusion It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to $ Temodal^{®} $ capsules of the same strength under fasting conditions. Trial registration https://www.chinadrugtrials.org.cn/index.html, CTR2017 0122. Temozolomide capsule (dpeaa)DE-He213 Gliomas (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Bioequivalence (dpeaa)DE-He213 Lin, Qingtang verfasserin aut Liu, Chuan verfasserin aut Liu, Jacqueline verfasserin aut Chen, Xiaobao verfasserin aut Li, Xinxia verfasserin aut Zhao, Guoguang verfasserin aut Zhang, Lan verfasserin aut Enthalten in Cancer chemotherapy and pharmacology Berlin : Springer, 1978 86(2020), 6 vom: 21. Okt., Seite 793-801 (DE-627)253390435 (DE-600)1458488-8 1432-0843 nnns volume:86 year:2020 number:6 day:21 month:10 pages:793-801 https://dx.doi.org/10.1007/s00280-020-04175-0 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE 44.38 ASE AR 86 2020 6 21 10 793-801 |
allfields_unstemmed |
10.1007/s00280-020-04175-0 doi (DE-627)SPR041724569 (SPR)s00280-020-04175-0-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl 44.38 bkl Hu, Chaoying verfasserin aut Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of $ Temodal^{®} $ and spread equally over days 3–5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration ($ C_{max} $), area under the concentration–time curve (AUC) 0-t, AUC 0-∞) fell within the equivalence boundary of 80–125%. Results Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for $ C_{max} $ (91.08%, 106.18%), $ AUC_{0-t} $ (98.62%,102.18%), and $ AUC_{0-∞} $ (98.65%, 102.21%) was well within the 80%–125% range for the 20-mg capsule, as was the $ C_{max} $ (90.49%, 113.32%), $ AUC_{0-t} $ (99.89%, 104.63%) and $ AUC_{0-∞} $ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients. Conclusion It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to $ Temodal^{®} $ capsules of the same strength under fasting conditions. Trial registration https://www.chinadrugtrials.org.cn/index.html, CTR2017 0122. Temozolomide capsule (dpeaa)DE-He213 Gliomas (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Bioequivalence (dpeaa)DE-He213 Lin, Qingtang verfasserin aut Liu, Chuan verfasserin aut Liu, Jacqueline verfasserin aut Chen, Xiaobao verfasserin aut Li, Xinxia verfasserin aut Zhao, Guoguang verfasserin aut Zhang, Lan verfasserin aut Enthalten in Cancer chemotherapy and pharmacology Berlin : Springer, 1978 86(2020), 6 vom: 21. Okt., Seite 793-801 (DE-627)253390435 (DE-600)1458488-8 1432-0843 nnns volume:86 year:2020 number:6 day:21 month:10 pages:793-801 https://dx.doi.org/10.1007/s00280-020-04175-0 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE 44.38 ASE AR 86 2020 6 21 10 793-801 |
allfieldsGer |
10.1007/s00280-020-04175-0 doi (DE-627)SPR041724569 (SPR)s00280-020-04175-0-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl 44.38 bkl Hu, Chaoying verfasserin aut Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of $ Temodal^{®} $ and spread equally over days 3–5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration ($ C_{max} $), area under the concentration–time curve (AUC) 0-t, AUC 0-∞) fell within the equivalence boundary of 80–125%. Results Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for $ C_{max} $ (91.08%, 106.18%), $ AUC_{0-t} $ (98.62%,102.18%), and $ AUC_{0-∞} $ (98.65%, 102.21%) was well within the 80%–125% range for the 20-mg capsule, as was the $ C_{max} $ (90.49%, 113.32%), $ AUC_{0-t} $ (99.89%, 104.63%) and $ AUC_{0-∞} $ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients. Conclusion It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to $ Temodal^{®} $ capsules of the same strength under fasting conditions. Trial registration https://www.chinadrugtrials.org.cn/index.html, CTR2017 0122. Temozolomide capsule (dpeaa)DE-He213 Gliomas (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Bioequivalence (dpeaa)DE-He213 Lin, Qingtang verfasserin aut Liu, Chuan verfasserin aut Liu, Jacqueline verfasserin aut Chen, Xiaobao verfasserin aut Li, Xinxia verfasserin aut Zhao, Guoguang verfasserin aut Zhang, Lan verfasserin aut Enthalten in Cancer chemotherapy and pharmacology Berlin : Springer, 1978 86(2020), 6 vom: 21. Okt., Seite 793-801 (DE-627)253390435 (DE-600)1458488-8 1432-0843 nnns volume:86 year:2020 number:6 day:21 month:10 pages:793-801 https://dx.doi.org/10.1007/s00280-020-04175-0 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE 44.38 ASE AR 86 2020 6 21 10 793-801 |
allfieldsSound |
10.1007/s00280-020-04175-0 doi (DE-627)SPR041724569 (SPR)s00280-020-04175-0-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl 44.38 bkl Hu, Chaoying verfasserin aut Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of $ Temodal^{®} $ and spread equally over days 3–5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration ($ C_{max} $), area under the concentration–time curve (AUC) 0-t, AUC 0-∞) fell within the equivalence boundary of 80–125%. Results Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for $ C_{max} $ (91.08%, 106.18%), $ AUC_{0-t} $ (98.62%,102.18%), and $ AUC_{0-∞} $ (98.65%, 102.21%) was well within the 80%–125% range for the 20-mg capsule, as was the $ C_{max} $ (90.49%, 113.32%), $ AUC_{0-t} $ (99.89%, 104.63%) and $ AUC_{0-∞} $ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients. Conclusion It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to $ Temodal^{®} $ capsules of the same strength under fasting conditions. Trial registration https://www.chinadrugtrials.org.cn/index.html, CTR2017 0122. Temozolomide capsule (dpeaa)DE-He213 Gliomas (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Bioequivalence (dpeaa)DE-He213 Lin, Qingtang verfasserin aut Liu, Chuan verfasserin aut Liu, Jacqueline verfasserin aut Chen, Xiaobao verfasserin aut Li, Xinxia verfasserin aut Zhao, Guoguang verfasserin aut Zhang, Lan verfasserin aut Enthalten in Cancer chemotherapy and pharmacology Berlin : Springer, 1978 86(2020), 6 vom: 21. Okt., Seite 793-801 (DE-627)253390435 (DE-600)1458488-8 1432-0843 nnns volume:86 year:2020 number:6 day:21 month:10 pages:793-801 https://dx.doi.org/10.1007/s00280-020-04175-0 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE 44.38 ASE AR 86 2020 6 21 10 793-801 |
language |
English |
source |
Enthalten in Cancer chemotherapy and pharmacology 86(2020), 6 vom: 21. Okt., Seite 793-801 volume:86 year:2020 number:6 day:21 month:10 pages:793-801 |
sourceStr |
Enthalten in Cancer chemotherapy and pharmacology 86(2020), 6 vom: 21. Okt., Seite 793-801 volume:86 year:2020 number:6 day:21 month:10 pages:793-801 |
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Article |
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topic_facet |
Temozolomide capsule Gliomas Pharmacokinetics Bioequivalence |
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container_title |
Cancer chemotherapy and pharmacology |
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Hu, Chaoying @@aut@@ Lin, Qingtang @@aut@@ Liu, Chuan @@aut@@ Liu, Jacqueline @@aut@@ Chen, Xiaobao @@aut@@ Li, Xinxia @@aut@@ Zhao, Guoguang @@aut@@ Zhang, Lan @@aut@@ |
publishDateDaySort_date |
2020-10-21T00:00:00Z |
hierarchy_top_id |
253390435 |
dewey-sort |
3610 |
id |
SPR041724569 |
language_de |
englisch |
fullrecord |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR041724569</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519140148.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201102s2020 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s00280-020-04175-0</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR041724569</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s00280-020-04175-0-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">ASE</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.40</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.38</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Hu, Chaoying</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2020</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of $ Temodal^{®} $ and spread equally over days 3–5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration ($ C_{max} $), area under the concentration–time curve (AUC) 0-t, AUC 0-∞) fell within the equivalence boundary of 80–125%. Results Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for $ C_{max} $ (91.08%, 106.18%), $ AUC_{0-t} $ (98.62%,102.18%), and $ AUC_{0-∞} $ (98.65%, 102.21%) was well within the 80%–125% range for the 20-mg capsule, as was the $ C_{max} $ (90.49%, 113.32%), $ AUC_{0-t} $ (99.89%, 104.63%) and $ AUC_{0-∞} $ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients. Conclusion It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to $ Temodal^{®} $ capsules of the same strength under fasting conditions. 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|
author |
Hu, Chaoying |
spellingShingle |
Hu, Chaoying ddc 610 bkl 44.40 bkl 44.38 misc Temozolomide capsule misc Gliomas misc Pharmacokinetics misc Bioequivalence Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China |
authorStr |
Hu, Chaoying |
ppnlink_with_tag_str_mv |
@@773@@(DE-627)253390435 |
format |
electronic Article |
dewey-ones |
610 - Medicine & health |
delete_txt_mv |
keep |
author_role |
aut aut aut aut aut aut aut aut |
collection |
springer |
remote_str |
true |
illustrated |
Not Illustrated |
issn |
1432-0843 |
topic_title |
610 ASE 44.40 bkl 44.38 bkl Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China Temozolomide capsule (dpeaa)DE-He213 Gliomas (dpeaa)DE-He213 Pharmacokinetics (dpeaa)DE-He213 Bioequivalence (dpeaa)DE-He213 |
topic |
ddc 610 bkl 44.40 bkl 44.38 misc Temozolomide capsule misc Gliomas misc Pharmacokinetics misc Bioequivalence |
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ddc 610 bkl 44.40 bkl 44.38 misc Temozolomide capsule misc Gliomas misc Pharmacokinetics misc Bioequivalence |
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Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China |
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Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China |
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Hu, Chaoying |
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Cancer chemotherapy and pharmacology |
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Hu, Chaoying Lin, Qingtang Liu, Chuan Liu, Jacqueline Chen, Xiaobao Li, Xinxia Zhao, Guoguang Zhang, Lan |
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bioequivalence study of 20-mg and 100-mg temozolomide capsules (toz309 and $ temodal^{®} $) in glioma patients in china |
title_auth |
Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China |
abstract |
Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of $ Temodal^{®} $ and spread equally over days 3–5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration ($ C_{max} $), area under the concentration–time curve (AUC) 0-t, AUC 0-∞) fell within the equivalence boundary of 80–125%. Results Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for $ C_{max} $ (91.08%, 106.18%), $ AUC_{0-t} $ (98.62%,102.18%), and $ AUC_{0-∞} $ (98.65%, 102.21%) was well within the 80%–125% range for the 20-mg capsule, as was the $ C_{max} $ (90.49%, 113.32%), $ AUC_{0-t} $ (99.89%, 104.63%) and $ AUC_{0-∞} $ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients. Conclusion It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to $ Temodal^{®} $ capsules of the same strength under fasting conditions. Trial registration https://www.chinadrugtrials.org.cn/index.html, CTR2017 0122. |
abstractGer |
Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of $ Temodal^{®} $ and spread equally over days 3–5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration ($ C_{max} $), area under the concentration–time curve (AUC) 0-t, AUC 0-∞) fell within the equivalence boundary of 80–125%. Results Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for $ C_{max} $ (91.08%, 106.18%), $ AUC_{0-t} $ (98.62%,102.18%), and $ AUC_{0-∞} $ (98.65%, 102.21%) was well within the 80%–125% range for the 20-mg capsule, as was the $ C_{max} $ (90.49%, 113.32%), $ AUC_{0-t} $ (99.89%, 104.63%) and $ AUC_{0-∞} $ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients. Conclusion It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to $ Temodal^{®} $ capsules of the same strength under fasting conditions. Trial registration https://www.chinadrugtrials.org.cn/index.html, CTR2017 0122. |
abstract_unstemmed |
Background Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. The rest of the prescribed dose was administered in the form of $ Temodal^{®} $ and spread equally over days 3–5. Blood samples were obtained for pharmacokinetic evaluation on days 1 and 2. Bioequivalence was demonstrated if the geometric means ratio of the three main pharmacokinetic parameters (mean maximum plasma concentration ($ C_{max} $), area under the concentration–time curve (AUC) 0-t, AUC 0-∞) fell within the equivalence boundary of 80–125%. Results Twenty-nine glioblastoma multiforme or anaplastic astrocytoma patients were enrolled and dosed with the test and reference formulations under fasting conditions. The 90% confidence interval of the geometric means ratio for $ C_{max} $ (91.08%, 106.18%), $ AUC_{0-t} $ (98.62%,102.18%), and $ AUC_{0-∞} $ (98.65%, 102.21%) was well within the 80%–125% range for the 20-mg capsule, as was the $ C_{max} $ (90.49%, 113.32%), $ AUC_{0-t} $ (99.89%, 104.63%) and $ AUC_{0-∞} $ (99.99%, 104.67%) for the 100-mg capsule drug product. Additionally, all the secondary pharmacokinetic parameters were not significantly different. After two cycles of treatment, there was no mortality among the 29 patients, treatment-related severe adverse events, or events that would require study discontinuation; however, one significant adverse effect (life-threatening seizures) occurred and was related to disease progression. Adverse events were reported in 82.8% (24/29) patients, and treatment emergent adverse events were reported in 72.4% (21/29) patients. Conclusion It can be concluded that 20-mg and 100-mg capsules of TOZ309 are bioequivalent to $ Temodal^{®} $ capsules of the same strength under fasting conditions. Trial registration https://www.chinadrugtrials.org.cn/index.html, CTR2017 0122. |
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title_short |
Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and $ Temodal^{®} $) in glioma patients in China |
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https://dx.doi.org/10.1007/s00280-020-04175-0 |
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The aim of this study was to confirm the bioequivalence and safety of two strengths (20–100 mg) of generic temozolomide in the form of TOZ039 and $ Temodal^{®} $ capsules administered to brain tumor patients. Study design An open-label, randomized, two-phase, two-period, crossover pharmacokinetic study was performed in a single institution. The reference and test drugs were prescribed at a dose of 150 mg/$ m^{2} $ daily from days 1 to 5 of a 28-day cycle in the first phase; in the second phase, either a 150- or 200-mg/$ m^{2} $ dose was prescribed, depending on patient tolerance. On days 1 and 2 of each phase, a fixed 200-mg dose was administered either as ten 20-mg capsules in the first cycle or two 100-mg capsules in the second cycle. Drug administration in the first two days was randomized, i.e., if TOZ309 was administered on day 1, $ Temodal^{®} $ was administered on day 2, and vice versa. 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|
score |
7.39787 |