Bioequivalence of tamoxifen citrate capsules in healthy volunteers
文献类型：期刊论文
| 作者 | SHI Shaojun1; LI Zhongfang1; XU Shunqing2; CHEN Xiaoyan3 ; ZHONG Dafang3; CHEN Huating1; ZENG Fandian2
|
| 刊名 | Chinese Journal of Hospital Pharmacy
 |
| 出版日期 | 2008 |
| 卷号 | 28期号:19页码:1668-1672 |
| 关键词 | tamoxifen citrate LC/MS/MS bioavailability bioequivalence |
| ISSN号 | 1001-5213 |
| 其他题名 | 枸橼酸他莫昔芬胶囊的人体生物等效性 |
| 文献子类 | Article |
| 英文摘要 | OBJECTIVE To evaluate the relative bioavailability and bioequivalence of tamoxifen citrate capsules in healthy volunteers. METHODS A single oral close of 40 mg tamoxifen citrate test and reference preparations were given to 20 male healthy volunteers in a randomized crossover design. Tamoxifen concentrations in plasma were determined by LC/MS/MS. The pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations. RESULTS The main pharmacokinetic parameters of tamoxifen citrate test and reference preparations were as follow, t_(1/2)were （53. 5 14. 4） h and （51.7 8. 9） h; t_(max) were （3. 9 0. 9） h and （4. 0 1.1） h; C_(max) were （108. 1 19. 8）mug·L~(-1) and （101.3 16. 5） mug·L~(-1) ; AUC_(0-72) were （3 073. 7 439. 1 ） mug·h·L~(-1) and （3 148. 8 373. 7）mug·h·L~(-1) AUG_(0-) were （5 074. 8 1 082.2） mug·h·L~(-1) and （5 121.2 902. 0）mug·h·L~(-1), respectively. The differences of the major pharmacokinetic parameters between test and reference preparations were not significant. The relative bioavailability of test preparation was （97.9 10. 8） %. CONCLUSION The statistical analysis of the results shows that the two preparations are bioequivalent. |
| WOS研究方向 | Pharmacology & Pharmacy (provided by Clarivate Analytics) |
| 语种 | 中文 |
| CSCD记录号 | CSCD:3392585 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/268042]  |
| 专题 | 上海药物代谢研究中心 |
| 作者单位 | 1.Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430022, China.; 2.Institute of Clinical Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.; 3.Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Center for Drug Metabolism and Pharmacokinetics Research, Shanghai 201203, China. |
| 推荐引用方式 GB/T 7714 | SHI Shaojun,LI Zhongfang,XU Shunqing,et al. Bioequivalence of tamoxifen citrate capsules in healthy volunteers[J]. Chinese Journal of Hospital Pharmacy,2008,28(19):1668-1672. |
| APA | SHI Shaojun.,LI Zhongfang.,XU Shunqing.,CHEN Xiaoyan.,ZHONG Dafang.,...&ZENG Fandian.(2008).Bioequivalence of tamoxifen citrate capsules in healthy volunteers.Chinese Journal of Hospital Pharmacy,28(19),1668-1672. |
| MLA | SHI Shaojun,et al."Bioequivalence of tamoxifen citrate capsules in healthy volunteers".Chinese Journal of Hospital Pharmacy 28.19(2008):1668-1672. |
入库方式： OAI收割
来源：上海药物研究所
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