Pharmacokinetics and bioequivalence of atorvastatin calcium tablets in healthy male Chinese volunteers
文献类型：期刊论文
| 作者 | Shen Yi; Zhang Yifan ; Chen Xiaoyan; Guo Lixia; Zhong Dafang
|
| 刊名 | Chinese Journal of Cardiology
 |
| 出版日期 | 2012 |
| 卷号 | 40期号:3页码:243-247 |
| 关键词 | Atorvastatin Pharmacokinetics Bioequivalence |
| ISSN号 | 0253-3758 |
| 其他题名 | 阿托伐他汀在中国健康男性志愿者体内的药代动力学及生物等效性 |
| 文献子类 | Article |
| 英文摘要 | Objective To compare the bioequivalence and pharmacokinetics of national made and imported atorvastatin in healthy male Chinese volunteers after single oral administration. Methods This randomized sequence, open-label, two-period crossover study with a one-week washout period between doses was performed in 24 fasting healthy Chinese males. They were randomly assigned to receive 20 mg of either the test (national made) or reference (imported) formulation orally. The blood samples were collected over a 72-hour period. Plasma concentrations of parent atorvastatin (AT)，ortho-hydroxy-atorvastatin (o-OAT) and para-hydroxy-atorvastatin (p-OAT) were simultaneously determined using the validated liquid chromatography-tandem mass spectrometry method，the bioequivalence was also evaluated throughout the study. Results The main pharmacokinetic parameters of test and reference formulations were as follows : the values of C_(max) for AT were (10. 6 11. 9) mug/L and (10. 6 9. 8) mug/L, t_(1/2z) were (11. 4 3. 9) h and (11.4 5. 3) h, AUC_(0-t) were (54. 2 37. 4) mug?h~(-1)?L~(-1) and (51.7 34. 1) mug?h~(-1)?L~(-1)，respectively. The values of C_(max) for o-OAT were (7.84.5) mug/L and (7.64.3) mug/L, t_(1/2z) were (12.3 4.2) h and (11.9 3.4) h, AUC_(0-t) were (96. 8 48. 2) mug?h~(-1)?L~(-1) and (92.3 44.4) mug?h~(-1)?L~(-1), respectively. The values of C_(max) for p-OAT were (0. 5 0. 4) mug/L and (0. 4 0. 3) mug/L, t_(l/2z) were (18. 4 12. 4) h and (23. 3 17. 8) h，AUC_(0-t), were (15. 9 12. 3) mug ? h~(-1)?L~(-1) and (13. 8 8. 11) mug ? h~(-1)?L~(-1)， respectively. The relative bioavailability of AT and o-OAT in test formulation were (105. 3 20. 7) % and (107. 8 23. 2) %, respectively. The 90% confidence interval of the test/reference geometric mean ratios of AUC_(0-t) for AT and o-OAT were (97.7-110.5)% and (98.3-111.3)%, C_(max) for AT and o-OAT were (75. 8 - 114. 0) % and (90. 6 - 122. 9) %, they were all located within the bioequivalence criteria range (80% - 125% for AUC，and 70% - 143% for C_(max)). Conclusion The result demonstrated that two formulations were bioequivalent. |
| WOS研究方向 | General & Internal Medicine (provided by Clarivate Analytics) |
| 语种 | 中文 |
| CSCD记录号 | CSCD:4527512 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/267857]  |
| 专题 | 上海药物代谢研究中心 |
| 通讯作者 | Zhong Dafang |
| 作者单位 | College of Pharmacy, Zhejiang University of Technology, Hangzhou, Zhejiang 310014, China. |
| 推荐引用方式 GB/T 7714 | Shen Yi,Zhang Yifan,Chen Xiaoyan,et al. Pharmacokinetics and bioequivalence of atorvastatin calcium tablets in healthy male Chinese volunteers[J]. Chinese Journal of Cardiology,2012,40(3):243-247. |
| APA | Shen Yi,Zhang Yifan,Chen Xiaoyan,Guo Lixia,&Zhong Dafang.(2012).Pharmacokinetics and bioequivalence of atorvastatin calcium tablets in healthy male Chinese volunteers.Chinese Journal of Cardiology,40(3),243-247. |
| MLA | Shen Yi,et al."Pharmacokinetics and bioequivalence of atorvastatin calcium tablets in healthy male Chinese volunteers".Chinese Journal of Cardiology 40.3(2012):243-247. |
入库方式： OAI收割
来源：上海药物研究所
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