中国药业2011，Vol.20Issue(1)：9-11,3.
拉米夫定片人体生物等效性研究
Bioequivalence Of oral Lamivudine Tablets in Healthy Volunteer
魏振满 1丁晋彪 1胡琳 1陈红鸽 1孙斌 1宫雯雯 1刘峰群1
作者信息
- 1. 中国人民解放军第302医院临床药理室,北京,100039
- 折叠
摘要
Abstract
Objective To study the bioavailability and bioequivalence of the tested and reference Lamivudine Tablets in healthy male volunteers. Methods According to the crossover design, each volunteer was orally given 100 mg Lamivudine Tablets. The plasma concentrations were determined by LC-MS/MS. The pharmacokinetic parameters were obtained using DAS program. Results Cmax were (1 160. 954 ± 282. 657)ng/mL and (1 090. 206 ± 311. 840)ng/mL, Tmax were (0. 908 ± 0. 356)h and (0. 789 ± 0. 240)h, t1/2 were (3. 642 ± 1.125)h and (3. 360± 1. 183)h, AUC0-t were (3 781. 871 ±684. 773)ng/(mL · h) and (3 534. 502 ±798. 057)ng/(mL · h), AUC0-∞ were (3 830. 838 ± 692. 358 ) ng / ( mL · h) and (3 585.388 ± 790. 932 ) ng / ( mL · h ), respectively. The relative bioavailability was ( 109. 0 ± 16.2 ) ％. The data of the reference and tested drugs were not obviously different. Conclusion The results show that the two Lamivudine Tablets made by two different corporations are bioequivalent.关键词
拉米夫定/生物等效性/液相色谱-串联质谱分类
医药卫生引用本文复制引用
魏振满,丁晋彪,胡琳,陈红鸽,孙斌,宫雯雯,刘峰群..拉米夫定片人体生物等效性研究[J].中国药业,2011,20(1):9-11,3.
