Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study

Objective We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured $ Glucophage^{®} $ immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. Methods T...
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Autor*in:	Hu, Chaoying [verfasserIn] Gao, Dan Li, Dandan Zhou, Dongli Zhang, Lan

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Anmerkung:	© The Author(s) 2022

Übergeordnetes Werk:	Enthalten in: Drugs in R & D - [S.l.] : Springer International, 1999, 22(2022), 4 vom: 20. Okt., Seite 301-309
Übergeordnetes Werk:	volume:22 ; year:2022 ; number:4 ; day:20 ; month:10 ; pages:301-309

Links:	Volltext

DOI / URN:	10.1007/s40268-022-00405-3

Katalog-ID:	SPR048724459

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520			\|a Objective We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured $ Glucophage^{®} $ immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. Methods This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time ($ AUC_{t} $) and maximum observed concentration (Cmax). Results In total, 96 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean $ AUC_{t} $ and Cmax (primary PK parameters) were comparable between the test and reference products. Point estimates for both parameters were close to 100% and the corresponding 90% confidence intervals were within the specified 80–125% bioequivalence boundary. There were no hypoglycemia-related adverse events (AEs) in either treatment group. All AEs in the present study were mild in severity. Conclusions Bioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated. Clinical Trials Registration This study was registered at ClinicalTrials.gov under the identifying number NCT03393208.
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allfields	10.1007/s40268-022-00405-3 doi (DE-627)SPR048724459 (SPR)s40268-022-00405-3-e DE-627 ger DE-627 rakwb eng Hu, Chaoying verfasserin (orcid)0000-0002-0116-4387 aut Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Objective We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured $ Glucophage^{®} $ immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. Methods This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time ($ AUC_{t} $) and maximum observed concentration (Cmax). Results In total, 96 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean $ AUC_{t} $ and Cmax (primary PK parameters) were comparable between the test and reference products. Point estimates for both parameters were close to 100% and the corresponding 90% confidence intervals were within the specified 80–125% bioequivalence boundary. There were no hypoglycemia-related adverse events (AEs) in either treatment group. All AEs in the present study were mild in severity. Conclusions Bioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated. Clinical Trials Registration This study was registered at ClinicalTrials.gov under the identifying number NCT03393208. Gao, Dan aut Li, Dandan aut Zhou, Dongli aut Zhang, Lan (orcid)0000-0002-5220-3171 aut Enthalten in Drugs in R & D [S.l.] : Springer International, 1999 22(2022), 4 vom: 20. Okt., Seite 301-309 (DE-627)357171527 (DE-600)2094513-9 1179-6901 nnns volume:22 year:2022 number:4 day:20 month:10 pages:301-309 https://dx.doi.org/10.1007/s40268-022-00405-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2022 4 20 10 301-309
spelling	10.1007/s40268-022-00405-3 doi (DE-627)SPR048724459 (SPR)s40268-022-00405-3-e DE-627 ger DE-627 rakwb eng Hu, Chaoying verfasserin (orcid)0000-0002-0116-4387 aut Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Objective We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured $ Glucophage^{®} $ immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. Methods This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time ($ AUC_{t} $) and maximum observed concentration (Cmax). Results In total, 96 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean $ AUC_{t} $ and Cmax (primary PK parameters) were comparable between the test and reference products. Point estimates for both parameters were close to 100% and the corresponding 90% confidence intervals were within the specified 80–125% bioequivalence boundary. There were no hypoglycemia-related adverse events (AEs) in either treatment group. All AEs in the present study were mild in severity. Conclusions Bioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated. Clinical Trials Registration This study was registered at ClinicalTrials.gov under the identifying number NCT03393208. Gao, Dan aut Li, Dandan aut Zhou, Dongli aut Zhang, Lan (orcid)0000-0002-5220-3171 aut Enthalten in Drugs in R & D [S.l.] : Springer International, 1999 22(2022), 4 vom: 20. Okt., Seite 301-309 (DE-627)357171527 (DE-600)2094513-9 1179-6901 nnns volume:22 year:2022 number:4 day:20 month:10 pages:301-309 https://dx.doi.org/10.1007/s40268-022-00405-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2022 4 20 10 301-309
allfields_unstemmed	10.1007/s40268-022-00405-3 doi (DE-627)SPR048724459 (SPR)s40268-022-00405-3-e DE-627 ger DE-627 rakwb eng Hu, Chaoying verfasserin (orcid)0000-0002-0116-4387 aut Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Objective We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured $ Glucophage^{®} $ immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. Methods This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time ($ AUC_{t} $) and maximum observed concentration (Cmax). Results In total, 96 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean $ AUC_{t} $ and Cmax (primary PK parameters) were comparable between the test and reference products. Point estimates for both parameters were close to 100% and the corresponding 90% confidence intervals were within the specified 80–125% bioequivalence boundary. There were no hypoglycemia-related adverse events (AEs) in either treatment group. All AEs in the present study were mild in severity. Conclusions Bioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated. Clinical Trials Registration This study was registered at ClinicalTrials.gov under the identifying number NCT03393208. Gao, Dan aut Li, Dandan aut Zhou, Dongli aut Zhang, Lan (orcid)0000-0002-5220-3171 aut Enthalten in Drugs in R & D [S.l.] : Springer International, 1999 22(2022), 4 vom: 20. Okt., Seite 301-309 (DE-627)357171527 (DE-600)2094513-9 1179-6901 nnns volume:22 year:2022 number:4 day:20 month:10 pages:301-309 https://dx.doi.org/10.1007/s40268-022-00405-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2022 4 20 10 301-309
allfieldsGer	10.1007/s40268-022-00405-3 doi (DE-627)SPR048724459 (SPR)s40268-022-00405-3-e DE-627 ger DE-627 rakwb eng Hu, Chaoying verfasserin (orcid)0000-0002-0116-4387 aut Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Objective We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured $ Glucophage^{®} $ immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. Methods This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time ($ AUC_{t} $) and maximum observed concentration (Cmax). Results In total, 96 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean $ AUC_{t} $ and Cmax (primary PK parameters) were comparable between the test and reference products. Point estimates for both parameters were close to 100% and the corresponding 90% confidence intervals were within the specified 80–125% bioequivalence boundary. There were no hypoglycemia-related adverse events (AEs) in either treatment group. All AEs in the present study were mild in severity. Conclusions Bioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated. Clinical Trials Registration This study was registered at ClinicalTrials.gov under the identifying number NCT03393208. Gao, Dan aut Li, Dandan aut Zhou, Dongli aut Zhang, Lan (orcid)0000-0002-5220-3171 aut Enthalten in Drugs in R & D [S.l.] : Springer International, 1999 22(2022), 4 vom: 20. Okt., Seite 301-309 (DE-627)357171527 (DE-600)2094513-9 1179-6901 nnns volume:22 year:2022 number:4 day:20 month:10 pages:301-309 https://dx.doi.org/10.1007/s40268-022-00405-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2022 4 20 10 301-309
allfieldsSound	10.1007/s40268-022-00405-3 doi (DE-627)SPR048724459 (SPR)s40268-022-00405-3-e DE-627 ger DE-627 rakwb eng Hu, Chaoying verfasserin (orcid)0000-0002-0116-4387 aut Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Objective We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured $ Glucophage^{®} $ immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. Methods This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time ($ AUC_{t} $) and maximum observed concentration (Cmax). Results In total, 96 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean $ AUC_{t} $ and Cmax (primary PK parameters) were comparable between the test and reference products. Point estimates for both parameters were close to 100% and the corresponding 90% confidence intervals were within the specified 80–125% bioequivalence boundary. There were no hypoglycemia-related adverse events (AEs) in either treatment group. All AEs in the present study were mild in severity. Conclusions Bioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated. Clinical Trials Registration This study was registered at ClinicalTrials.gov under the identifying number NCT03393208. Gao, Dan aut Li, Dandan aut Zhou, Dongli aut Zhang, Lan (orcid)0000-0002-5220-3171 aut Enthalten in Drugs in R & D [S.l.] : Springer International, 1999 22(2022), 4 vom: 20. Okt., Seite 301-309 (DE-627)357171527 (DE-600)2094513-9 1179-6901 nnns volume:22 year:2022 number:4 day:20 month:10 pages:301-309 https://dx.doi.org/10.1007/s40268-022-00405-3 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 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_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2022 4 20 10 301-309
language	English
source	Enthalten in Drugs in R & D 22(2022), 4 vom: 20. Okt., Seite 301-309 volume:22 year:2022 number:4 day:20 month:10 pages:301-309
sourceStr	Enthalten in Drugs in R & D 22(2022), 4 vom: 20. Okt., Seite 301-309 volume:22 year:2022 number:4 day:20 month:10 pages:301-309
format_phy_str_mv	Article
institution	findex.gbv.de
isfreeaccess_bool	true
container_title	Drugs in R & D
authorswithroles_txt_mv	Hu, Chaoying @@aut@@ Gao, Dan @@aut@@ Li, Dandan @@aut@@ Zhou, Dongli @@aut@@ Zhang, Lan @@aut@@
publishDateDaySort_date	2022-10-20T00:00:00Z
hierarchy_top_id	357171527
id	SPR048724459
language_de	englisch
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author	Hu, Chaoying
spellingShingle	Hu, Chaoying Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study
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topic_title	Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study
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title	Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study
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title_full	Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study
author_sort	Hu, Chaoying
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author_browse	Hu, Chaoying Gao, Dan Li, Dandan Zhou, Dongli Zhang, Lan
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author-letter	Hu, Chaoying
doi_str_mv	10.1007/s40268-022-00405-3
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title_sort	chinese- and french-manufactured immediate-release $ glucophage^{®} $ bioequivalence: a randomized, open-label, crossover study
title_auth	Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study
abstract	Objective We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured $ Glucophage^{®} $ immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. Methods This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time ($ AUC_{t} $) and maximum observed concentration (Cmax). Results In total, 96 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean $ AUC_{t} $ and Cmax (primary PK parameters) were comparable between the test and reference products. Point estimates for both parameters were close to 100% and the corresponding 90% confidence intervals were within the specified 80–125% bioequivalence boundary. There were no hypoglycemia-related adverse events (AEs) in either treatment group. All AEs in the present study were mild in severity. Conclusions Bioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated. Clinical Trials Registration This study was registered at ClinicalTrials.gov under the identifying number NCT03393208. © The Author(s) 2022
abstractGer	Objective We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured $ Glucophage^{®} $ immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. Methods This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time ($ AUC_{t} $) and maximum observed concentration (Cmax). Results In total, 96 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean $ AUC_{t} $ and Cmax (primary PK parameters) were comparable between the test and reference products. Point estimates for both parameters were close to 100% and the corresponding 90% confidence intervals were within the specified 80–125% bioequivalence boundary. There were no hypoglycemia-related adverse events (AEs) in either treatment group. All AEs in the present study were mild in severity. Conclusions Bioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated. Clinical Trials Registration This study was registered at ClinicalTrials.gov under the identifying number NCT03393208. © The Author(s) 2022
abstract_unstemmed	Objective We aimed to assess the bioequivalence, safety, and tolerability of Chinese- and French-manufactured $ Glucophage^{®} $ immediate-release (GIR) tablets under fasted and fed conditions in healthy volunteers. A bioequivalence study was proposed to support the manufacturing transfer. Methods This was an open-label, randomized, two-period, two-sequence, crossover study. Subjects were randomly assigned to receive the test product (one 500 mg GIR tablet manufactured in China) or reference product (one 500 mg GIR tablet manufactured in France). The primary study endpoint was the area under the plasma concentration-time curve from time zero to the last sampling time ($ AUC_{t} $) and maximum observed concentration (Cmax). Results In total, 96 subjects were screened and 44 subjects were randomly assigned to treatment (fasted group, 26 subjects; fed group, 18 subjects). All 44 subjects received the study drug, completed the study, and were included in the pharmacokinetic (PK) and safety analysis sets. Under fasted or fed conditions, the mean $ AUC_{t} $ and Cmax (primary PK parameters) were comparable between the test and reference products. Point estimates for both parameters were close to 100% and the corresponding 90% confidence intervals were within the specified 80–125% bioequivalence boundary. There were no hypoglycemia-related adverse events (AEs) in either treatment group. All AEs in the present study were mild in severity. Conclusions Bioequivalence between the test and reference GIR tablets was demonstrated under fasted and fed conditions and both were safe and well tolerated. Clinical Trials Registration This study was registered at ClinicalTrials.gov under the identifying number NCT03393208. © The Author(s) 2022
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title_short	Chinese- and French-Manufactured Immediate-Release $ Glucophage^{®} $ Bioequivalence: A Randomized, Open-Label, Crossover Study
url	https://dx.doi.org/10.1007/s40268-022-00405-3
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author2	Gao, Dan Li, Dandan Zhou, Dongli Zhang, Lan
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up_date	2024-07-03T21:04:40.435Z
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