Pharmacokinetic study of ranolazine in Chinese healthy volunteers
Objective To evaluate pharmacokinetics after administration of ranolazine sustained release tablets at a single and multiple dose to healthy Chinese volunteers. Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included,...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
YU Mingjie [verfasserIn] XIANG Rongfeng [verfasserIn] XIONG Lirong [verfasserIn] LI Xiaoyu [verfasserIn] DAI Qing [verfasserIn] CHEN Yongchuan [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Chinesisch |
| Erschienen: |
2019 |
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| Übergeordnetes Werk: |
In: Di-san junyi daxue xuebao - Editorial Office of Journal of Third Military Medical University, 2021, 41(2019), 2, Seite 177-182 |
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| Übergeordnetes Werk: |
volume:41 ; year:2019 ; number:2 ; pages:177-182 |
| Links: |
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| DOI / URN: |
10.16016/j.1000-5404.201808200 |
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| Katalog-ID: |
DOAJ070962715 |
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| 520 | |a Objective To evaluate pharmacokinetics after administration of ranolazine sustained release tablets at a single and multiple dose to healthy Chinese volunteers. Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included, and 500, 1 000 and 1 500 mg ranolazine sustained-release tablets were taken sequentially in 3 cycles. For the multiple-dose group, 10 individuals of both sexes were enrolled, and 500 and 1 000 mg ranolazine sustained-release tablets were sequentially administered in 2 cycles. The concentration of ranolazine in plasma samples was determined by LC-MS-MS, and the main pharmacokinetic parameters were calculated. Results The linear concentration of ranolazine in plasma ranged from 40 to 4 000 μg/L, and the LLOQ was 40 μg/L. The intra-assay and inter-assay precision were less than 15%. After single dose, the main parameters in doses 500, 1 000, 1 500 mg were Cmax: 774±157, 1 818±554 and 2 762±1 099 μg/L, respectively; tmax: 4.9±1.8, 4.9±2.6 and 4.9±1.5 h, respectively; t1/2z: 8.2±6.8, 10.3±8.7 and 9.7±12.0 h, respectively; AUC0-t: 8 470±2 765, 20 936±6 957 and 32 554±17 780 μg·h/L, respectively. After multiple dose, the main parameters in doses 500, 1 000 mg were Cmaxss: 1 826±904 and 3 635±620 μg/L; Cminss: 1 022±3 and 2 282±163 μg/L; Cav: 1 253±634 and 2 615±536 μg/L; AUC0-t: 22 452±12 359 and 53 232±15 909 μg·h/L; MRT0-t: 8.7±2.3 and 10.6±2.6; RAUC: 3.11±2.60 and 2.86±1.54. Conclusion In a single administration trial, Cmax and AUC are increased proportionally to the dose, and there is a good linear relationship between the three doses. Multiple dose tests have found that ranolazine has a certain accumulation in the body. | ||
| 650 | 4 | |a ranolazine | |
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| 700 | 0 | |a DAI Qing |e verfasserin |4 aut | |
| 700 | 0 | |a CHEN Yongchuan |e verfasserin |4 aut | |
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10.16016/j.1000-5404.201808200 doi (DE-627)DOAJ070962715 (DE-599)DOAJcb68139a02fd4c26aacb7315353ce4bc DE-627 ger DE-627 rakwb chi R5-920 YU Mingjie verfasserin aut Pharmacokinetic study of ranolazine in Chinese healthy volunteers 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective To evaluate pharmacokinetics after administration of ranolazine sustained release tablets at a single and multiple dose to healthy Chinese volunteers. Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included, and 500, 1 000 and 1 500 mg ranolazine sustained-release tablets were taken sequentially in 3 cycles. For the multiple-dose group, 10 individuals of both sexes were enrolled, and 500 and 1 000 mg ranolazine sustained-release tablets were sequentially administered in 2 cycles. The concentration of ranolazine in plasma samples was determined by LC-MS-MS, and the main pharmacokinetic parameters were calculated. Results The linear concentration of ranolazine in plasma ranged from 40 to 4 000 μg/L, and the LLOQ was 40 μg/L. The intra-assay and inter-assay precision were less than 15%. After single dose, the main parameters in doses 500, 1 000, 1 500 mg were Cmax: 774±157, 1 818±554 and 2 762±1 099 μg/L, respectively; tmax: 4.9±1.8, 4.9±2.6 and 4.9±1.5 h, respectively; t1/2z: 8.2±6.8, 10.3±8.7 and 9.7±12.0 h, respectively; AUC0-t: 8 470±2 765, 20 936±6 957 and 32 554±17 780 μg·h/L, respectively. After multiple dose, the main parameters in doses 500, 1 000 mg were Cmaxss: 1 826±904 and 3 635±620 μg/L; Cminss: 1 022±3 and 2 282±163 μg/L; Cav: 1 253±634 and 2 615±536 μg/L; AUC0-t: 22 452±12 359 and 53 232±15 909 μg·h/L; MRT0-t: 8.7±2.3 and 10.6±2.6; RAUC: 3.11±2.60 and 2.86±1.54. Conclusion In a single administration trial, Cmax and AUC are increased proportionally to the dose, and there is a good linear relationship between the three doses. Multiple dose tests have found that ranolazine has a certain accumulation in the body. ranolazine sustained release tablets hplc-ms-ms pharmacokinetics Medicine (General) XIANG Rongfeng verfasserin aut XIONG Lirong verfasserin aut LI Xiaoyu verfasserin aut DAI Qing verfasserin aut CHEN Yongchuan verfasserin aut In Di-san junyi daxue xuebao Editorial Office of Journal of Third Military Medical University, 2021 41(2019), 2, Seite 177-182 (DE-627)1760645346 10005404 nnns volume:41 year:2019 number:2 pages:177-182 https://doi.org/10.16016/j.1000-5404.201808200 kostenfrei https://doaj.org/article/cb68139a02fd4c26aacb7315353ce4bc kostenfrei http://aammt.tmmu.edu.cn/Upload/rhtml/201808200.htm kostenfrei https://doaj.org/toc/1000-5404 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ AR 41 2019 2 177-182 |
| spelling |
10.16016/j.1000-5404.201808200 doi (DE-627)DOAJ070962715 (DE-599)DOAJcb68139a02fd4c26aacb7315353ce4bc DE-627 ger DE-627 rakwb chi R5-920 YU Mingjie verfasserin aut Pharmacokinetic study of ranolazine in Chinese healthy volunteers 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective To evaluate pharmacokinetics after administration of ranolazine sustained release tablets at a single and multiple dose to healthy Chinese volunteers. Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included, and 500, 1 000 and 1 500 mg ranolazine sustained-release tablets were taken sequentially in 3 cycles. For the multiple-dose group, 10 individuals of both sexes were enrolled, and 500 and 1 000 mg ranolazine sustained-release tablets were sequentially administered in 2 cycles. The concentration of ranolazine in plasma samples was determined by LC-MS-MS, and the main pharmacokinetic parameters were calculated. Results The linear concentration of ranolazine in plasma ranged from 40 to 4 000 μg/L, and the LLOQ was 40 μg/L. The intra-assay and inter-assay precision were less than 15%. After single dose, the main parameters in doses 500, 1 000, 1 500 mg were Cmax: 774±157, 1 818±554 and 2 762±1 099 μg/L, respectively; tmax: 4.9±1.8, 4.9±2.6 and 4.9±1.5 h, respectively; t1/2z: 8.2±6.8, 10.3±8.7 and 9.7±12.0 h, respectively; AUC0-t: 8 470±2 765, 20 936±6 957 and 32 554±17 780 μg·h/L, respectively. After multiple dose, the main parameters in doses 500, 1 000 mg were Cmaxss: 1 826±904 and 3 635±620 μg/L; Cminss: 1 022±3 and 2 282±163 μg/L; Cav: 1 253±634 and 2 615±536 μg/L; AUC0-t: 22 452±12 359 and 53 232±15 909 μg·h/L; MRT0-t: 8.7±2.3 and 10.6±2.6; RAUC: 3.11±2.60 and 2.86±1.54. Conclusion In a single administration trial, Cmax and AUC are increased proportionally to the dose, and there is a good linear relationship between the three doses. Multiple dose tests have found that ranolazine has a certain accumulation in the body. ranolazine sustained release tablets hplc-ms-ms pharmacokinetics Medicine (General) XIANG Rongfeng verfasserin aut XIONG Lirong verfasserin aut LI Xiaoyu verfasserin aut DAI Qing verfasserin aut CHEN Yongchuan verfasserin aut In Di-san junyi daxue xuebao Editorial Office of Journal of Third Military Medical University, 2021 41(2019), 2, Seite 177-182 (DE-627)1760645346 10005404 nnns volume:41 year:2019 number:2 pages:177-182 https://doi.org/10.16016/j.1000-5404.201808200 kostenfrei https://doaj.org/article/cb68139a02fd4c26aacb7315353ce4bc kostenfrei http://aammt.tmmu.edu.cn/Upload/rhtml/201808200.htm kostenfrei https://doaj.org/toc/1000-5404 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ AR 41 2019 2 177-182 |
| allfields_unstemmed |
10.16016/j.1000-5404.201808200 doi (DE-627)DOAJ070962715 (DE-599)DOAJcb68139a02fd4c26aacb7315353ce4bc DE-627 ger DE-627 rakwb chi R5-920 YU Mingjie verfasserin aut Pharmacokinetic study of ranolazine in Chinese healthy volunteers 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective To evaluate pharmacokinetics after administration of ranolazine sustained release tablets at a single and multiple dose to healthy Chinese volunteers. Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included, and 500, 1 000 and 1 500 mg ranolazine sustained-release tablets were taken sequentially in 3 cycles. For the multiple-dose group, 10 individuals of both sexes were enrolled, and 500 and 1 000 mg ranolazine sustained-release tablets were sequentially administered in 2 cycles. The concentration of ranolazine in plasma samples was determined by LC-MS-MS, and the main pharmacokinetic parameters were calculated. Results The linear concentration of ranolazine in plasma ranged from 40 to 4 000 μg/L, and the LLOQ was 40 μg/L. The intra-assay and inter-assay precision were less than 15%. After single dose, the main parameters in doses 500, 1 000, 1 500 mg were Cmax: 774±157, 1 818±554 and 2 762±1 099 μg/L, respectively; tmax: 4.9±1.8, 4.9±2.6 and 4.9±1.5 h, respectively; t1/2z: 8.2±6.8, 10.3±8.7 and 9.7±12.0 h, respectively; AUC0-t: 8 470±2 765, 20 936±6 957 and 32 554±17 780 μg·h/L, respectively. After multiple dose, the main parameters in doses 500, 1 000 mg were Cmaxss: 1 826±904 and 3 635±620 μg/L; Cminss: 1 022±3 and 2 282±163 μg/L; Cav: 1 253±634 and 2 615±536 μg/L; AUC0-t: 22 452±12 359 and 53 232±15 909 μg·h/L; MRT0-t: 8.7±2.3 and 10.6±2.6; RAUC: 3.11±2.60 and 2.86±1.54. Conclusion In a single administration trial, Cmax and AUC are increased proportionally to the dose, and there is a good linear relationship between the three doses. Multiple dose tests have found that ranolazine has a certain accumulation in the body. ranolazine sustained release tablets hplc-ms-ms pharmacokinetics Medicine (General) XIANG Rongfeng verfasserin aut XIONG Lirong verfasserin aut LI Xiaoyu verfasserin aut DAI Qing verfasserin aut CHEN Yongchuan verfasserin aut In Di-san junyi daxue xuebao Editorial Office of Journal of Third Military Medical University, 2021 41(2019), 2, Seite 177-182 (DE-627)1760645346 10005404 nnns volume:41 year:2019 number:2 pages:177-182 https://doi.org/10.16016/j.1000-5404.201808200 kostenfrei https://doaj.org/article/cb68139a02fd4c26aacb7315353ce4bc kostenfrei http://aammt.tmmu.edu.cn/Upload/rhtml/201808200.htm kostenfrei https://doaj.org/toc/1000-5404 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ AR 41 2019 2 177-182 |
| allfieldsGer |
10.16016/j.1000-5404.201808200 doi (DE-627)DOAJ070962715 (DE-599)DOAJcb68139a02fd4c26aacb7315353ce4bc DE-627 ger DE-627 rakwb chi R5-920 YU Mingjie verfasserin aut Pharmacokinetic study of ranolazine in Chinese healthy volunteers 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective To evaluate pharmacokinetics after administration of ranolazine sustained release tablets at a single and multiple dose to healthy Chinese volunteers. Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included, and 500, 1 000 and 1 500 mg ranolazine sustained-release tablets were taken sequentially in 3 cycles. For the multiple-dose group, 10 individuals of both sexes were enrolled, and 500 and 1 000 mg ranolazine sustained-release tablets were sequentially administered in 2 cycles. The concentration of ranolazine in plasma samples was determined by LC-MS-MS, and the main pharmacokinetic parameters were calculated. Results The linear concentration of ranolazine in plasma ranged from 40 to 4 000 μg/L, and the LLOQ was 40 μg/L. The intra-assay and inter-assay precision were less than 15%. After single dose, the main parameters in doses 500, 1 000, 1 500 mg were Cmax: 774±157, 1 818±554 and 2 762±1 099 μg/L, respectively; tmax: 4.9±1.8, 4.9±2.6 and 4.9±1.5 h, respectively; t1/2z: 8.2±6.8, 10.3±8.7 and 9.7±12.0 h, respectively; AUC0-t: 8 470±2 765, 20 936±6 957 and 32 554±17 780 μg·h/L, respectively. After multiple dose, the main parameters in doses 500, 1 000 mg were Cmaxss: 1 826±904 and 3 635±620 μg/L; Cminss: 1 022±3 and 2 282±163 μg/L; Cav: 1 253±634 and 2 615±536 μg/L; AUC0-t: 22 452±12 359 and 53 232±15 909 μg·h/L; MRT0-t: 8.7±2.3 and 10.6±2.6; RAUC: 3.11±2.60 and 2.86±1.54. Conclusion In a single administration trial, Cmax and AUC are increased proportionally to the dose, and there is a good linear relationship between the three doses. Multiple dose tests have found that ranolazine has a certain accumulation in the body. ranolazine sustained release tablets hplc-ms-ms pharmacokinetics Medicine (General) XIANG Rongfeng verfasserin aut XIONG Lirong verfasserin aut LI Xiaoyu verfasserin aut DAI Qing verfasserin aut CHEN Yongchuan verfasserin aut In Di-san junyi daxue xuebao Editorial Office of Journal of Third Military Medical University, 2021 41(2019), 2, Seite 177-182 (DE-627)1760645346 10005404 nnns volume:41 year:2019 number:2 pages:177-182 https://doi.org/10.16016/j.1000-5404.201808200 kostenfrei https://doaj.org/article/cb68139a02fd4c26aacb7315353ce4bc kostenfrei http://aammt.tmmu.edu.cn/Upload/rhtml/201808200.htm kostenfrei https://doaj.org/toc/1000-5404 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ AR 41 2019 2 177-182 |
| allfieldsSound |
10.16016/j.1000-5404.201808200 doi (DE-627)DOAJ070962715 (DE-599)DOAJcb68139a02fd4c26aacb7315353ce4bc DE-627 ger DE-627 rakwb chi R5-920 YU Mingjie verfasserin aut Pharmacokinetic study of ranolazine in Chinese healthy volunteers 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective To evaluate pharmacokinetics after administration of ranolazine sustained release tablets at a single and multiple dose to healthy Chinese volunteers. Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included, and 500, 1 000 and 1 500 mg ranolazine sustained-release tablets were taken sequentially in 3 cycles. For the multiple-dose group, 10 individuals of both sexes were enrolled, and 500 and 1 000 mg ranolazine sustained-release tablets were sequentially administered in 2 cycles. The concentration of ranolazine in plasma samples was determined by LC-MS-MS, and the main pharmacokinetic parameters were calculated. Results The linear concentration of ranolazine in plasma ranged from 40 to 4 000 μg/L, and the LLOQ was 40 μg/L. The intra-assay and inter-assay precision were less than 15%. After single dose, the main parameters in doses 500, 1 000, 1 500 mg were Cmax: 774±157, 1 818±554 and 2 762±1 099 μg/L, respectively; tmax: 4.9±1.8, 4.9±2.6 and 4.9±1.5 h, respectively; t1/2z: 8.2±6.8, 10.3±8.7 and 9.7±12.0 h, respectively; AUC0-t: 8 470±2 765, 20 936±6 957 and 32 554±17 780 μg·h/L, respectively. After multiple dose, the main parameters in doses 500, 1 000 mg were Cmaxss: 1 826±904 and 3 635±620 μg/L; Cminss: 1 022±3 and 2 282±163 μg/L; Cav: 1 253±634 and 2 615±536 μg/L; AUC0-t: 22 452±12 359 and 53 232±15 909 μg·h/L; MRT0-t: 8.7±2.3 and 10.6±2.6; RAUC: 3.11±2.60 and 2.86±1.54. Conclusion In a single administration trial, Cmax and AUC are increased proportionally to the dose, and there is a good linear relationship between the three doses. Multiple dose tests have found that ranolazine has a certain accumulation in the body. ranolazine sustained release tablets hplc-ms-ms pharmacokinetics Medicine (General) XIANG Rongfeng verfasserin aut XIONG Lirong verfasserin aut LI Xiaoyu verfasserin aut DAI Qing verfasserin aut CHEN Yongchuan verfasserin aut In Di-san junyi daxue xuebao Editorial Office of Journal of Third Military Medical University, 2021 41(2019), 2, Seite 177-182 (DE-627)1760645346 10005404 nnns volume:41 year:2019 number:2 pages:177-182 https://doi.org/10.16016/j.1000-5404.201808200 kostenfrei https://doaj.org/article/cb68139a02fd4c26aacb7315353ce4bc kostenfrei http://aammt.tmmu.edu.cn/Upload/rhtml/201808200.htm kostenfrei https://doaj.org/toc/1000-5404 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ AR 41 2019 2 177-182 |
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Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included, and 500, 1 000 and 1 500 mg ranolazine sustained-release tablets were taken sequentially in 3 cycles. For the multiple-dose group, 10 individuals of both sexes were enrolled, and 500 and 1 000 mg ranolazine sustained-release tablets were sequentially administered in 2 cycles. The concentration of ranolazine in plasma samples was determined by LC-MS-MS, and the main pharmacokinetic parameters were calculated. Results The linear concentration of ranolazine in plasma ranged from 40 to 4 000 μg/L, and the LLOQ was 40 μg/L. The intra-assay and inter-assay precision were less than 15%. After single dose, the main parameters in doses 500, 1 000, 1 500 mg were Cmax: 774±157, 1 818±554 and 2 762±1 099 μg/L, respectively; tmax: 4.9±1.8, 4.9±2.6 and 4.9±1.5 h, respectively; t1/2z: 8.2±6.8, 10.3±8.7 and 9.7±12.0 h, respectively; AUC0-t: 8 470±2 765, 20 936±6 957 and 32 554±17 780 μg·h/L, respectively. After multiple dose, the main parameters in doses 500, 1 000 mg were Cmaxss: 1 826±904 and 3 635±620 μg/L; Cminss: 1 022±3 and 2 282±163 μg/L; Cav: 1 253±634 and 2 615±536 μg/L; AUC0-t: 22 452±12 359 and 53 232±15 909 μg·h/L; MRT0-t: 8.7±2.3 and 10.6±2.6; RAUC: 3.11±2.60 and 2.86±1.54. Conclusion In a single administration trial, Cmax and AUC are increased proportionally to the dose, and there is a good linear relationship between the three doses. 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YU Mingjie XIANG Rongfeng XIONG Lirong LI Xiaoyu DAI Qing CHEN Yongchuan |
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pharmacokinetic study of ranolazine in chinese healthy volunteers |
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Pharmacokinetic study of ranolazine in Chinese healthy volunteers |
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Objective To evaluate pharmacokinetics after administration of ranolazine sustained release tablets at a single and multiple dose to healthy Chinese volunteers. Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included, and 500, 1 000 and 1 500 mg ranolazine sustained-release tablets were taken sequentially in 3 cycles. For the multiple-dose group, 10 individuals of both sexes were enrolled, and 500 and 1 000 mg ranolazine sustained-release tablets were sequentially administered in 2 cycles. The concentration of ranolazine in plasma samples was determined by LC-MS-MS, and the main pharmacokinetic parameters were calculated. Results The linear concentration of ranolazine in plasma ranged from 40 to 4 000 μg/L, and the LLOQ was 40 μg/L. The intra-assay and inter-assay precision were less than 15%. After single dose, the main parameters in doses 500, 1 000, 1 500 mg were Cmax: 774±157, 1 818±554 and 2 762±1 099 μg/L, respectively; tmax: 4.9±1.8, 4.9±2.6 and 4.9±1.5 h, respectively; t1/2z: 8.2±6.8, 10.3±8.7 and 9.7±12.0 h, respectively; AUC0-t: 8 470±2 765, 20 936±6 957 and 32 554±17 780 μg·h/L, respectively. After multiple dose, the main parameters in doses 500, 1 000 mg were Cmaxss: 1 826±904 and 3 635±620 μg/L; Cminss: 1 022±3 and 2 282±163 μg/L; Cav: 1 253±634 and 2 615±536 μg/L; AUC0-t: 22 452±12 359 and 53 232±15 909 μg·h/L; MRT0-t: 8.7±2.3 and 10.6±2.6; RAUC: 3.11±2.60 and 2.86±1.54. Conclusion In a single administration trial, Cmax and AUC are increased proportionally to the dose, and there is a good linear relationship between the three doses. Multiple dose tests have found that ranolazine has a certain accumulation in the body. |
| abstractGer |
Objective To evaluate pharmacokinetics after administration of ranolazine sustained release tablets at a single and multiple dose to healthy Chinese volunteers. Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included, and 500, 1 000 and 1 500 mg ranolazine sustained-release tablets were taken sequentially in 3 cycles. For the multiple-dose group, 10 individuals of both sexes were enrolled, and 500 and 1 000 mg ranolazine sustained-release tablets were sequentially administered in 2 cycles. The concentration of ranolazine in plasma samples was determined by LC-MS-MS, and the main pharmacokinetic parameters were calculated. Results The linear concentration of ranolazine in plasma ranged from 40 to 4 000 μg/L, and the LLOQ was 40 μg/L. The intra-assay and inter-assay precision were less than 15%. After single dose, the main parameters in doses 500, 1 000, 1 500 mg were Cmax: 774±157, 1 818±554 and 2 762±1 099 μg/L, respectively; tmax: 4.9±1.8, 4.9±2.6 and 4.9±1.5 h, respectively; t1/2z: 8.2±6.8, 10.3±8.7 and 9.7±12.0 h, respectively; AUC0-t: 8 470±2 765, 20 936±6 957 and 32 554±17 780 μg·h/L, respectively. After multiple dose, the main parameters in doses 500, 1 000 mg were Cmaxss: 1 826±904 and 3 635±620 μg/L; Cminss: 1 022±3 and 2 282±163 μg/L; Cav: 1 253±634 and 2 615±536 μg/L; AUC0-t: 22 452±12 359 and 53 232±15 909 μg·h/L; MRT0-t: 8.7±2.3 and 10.6±2.6; RAUC: 3.11±2.60 and 2.86±1.54. Conclusion In a single administration trial, Cmax and AUC are increased proportionally to the dose, and there is a good linear relationship between the three doses. Multiple dose tests have found that ranolazine has a certain accumulation in the body. |
| abstract_unstemmed |
Objective To evaluate pharmacokinetics after administration of ranolazine sustained release tablets at a single and multiple dose to healthy Chinese volunteers. Methods A self-controlled trial design was used. In the single-time group, 10 healthy volunteers, half male and half female, were included, and 500, 1 000 and 1 500 mg ranolazine sustained-release tablets were taken sequentially in 3 cycles. For the multiple-dose group, 10 individuals of both sexes were enrolled, and 500 and 1 000 mg ranolazine sustained-release tablets were sequentially administered in 2 cycles. The concentration of ranolazine in plasma samples was determined by LC-MS-MS, and the main pharmacokinetic parameters were calculated. Results The linear concentration of ranolazine in plasma ranged from 40 to 4 000 μg/L, and the LLOQ was 40 μg/L. The intra-assay and inter-assay precision were less than 15%. After single dose, the main parameters in doses 500, 1 000, 1 500 mg were Cmax: 774±157, 1 818±554 and 2 762±1 099 μg/L, respectively; tmax: 4.9±1.8, 4.9±2.6 and 4.9±1.5 h, respectively; t1/2z: 8.2±6.8, 10.3±8.7 and 9.7±12.0 h, respectively; AUC0-t: 8 470±2 765, 20 936±6 957 and 32 554±17 780 μg·h/L, respectively. After multiple dose, the main parameters in doses 500, 1 000 mg were Cmaxss: 1 826±904 and 3 635±620 μg/L; Cminss: 1 022±3 and 2 282±163 μg/L; Cav: 1 253±634 and 2 615±536 μg/L; AUC0-t: 22 452±12 359 and 53 232±15 909 μg·h/L; MRT0-t: 8.7±2.3 and 10.6±2.6; RAUC: 3.11±2.60 and 2.86±1.54. Conclusion In a single administration trial, Cmax and AUC are increased proportionally to the dose, and there is a good linear relationship between the three doses. Multiple dose tests have found that ranolazine has a certain accumulation in the body. |
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