中国临床药学杂志2013，Vol.22Issue(2)：86-90,5.
拉米夫定片人体生物等效性评价
Evaluation on bioequivalence of lamivudine tablets in healthy volunteers
马媛媛 1葛庆华 1丁存刚 1周臻 1李雪宁1
作者信息
摘要
Abstract
AIM To evaluate the bioequivalence of lamivudine tablets in healthy male volunteers. METHODS Twenty-two healthy volunteers in randomized 2×2 crossover study were given a single oral 100 mg dose of test or reference lamivudine tablets. The plasma concentrations were determined by LC-MS/MS, and the pharmacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS program. RESULTS The main pharmacokinetic parameters for test and reference formulations were as follows: pmax were ( 881.4 ± 236. 8) and (985.0 ± 292.4)μg·L-1,tmaxwere(0.989±0.323)and(1.034±0.651)h,t1/2 were(2.889 ± 0.622)and(2.820 ± 0.368)h, AUC0→t were(3 435±627.7)and(3 504 ± 506.7)μg·h·L-1, AUC0→∞ were(3 529 ± 630.9)and(3 592 ±519.4) μg·h·L-1,respectively.The relative bioavailability of lamivudine was(98.45 ± 13.50)% . CONCLUSION The results show that the two lamivudine tablets made by two different corporations are bioequivalent. 关键词
拉米夫定/LC-MS/MS/药动学参数/生物等效性Key words
lamivudine/LC-MS/MS/pharmacokinetics/bioequivalence引用本文复制引用
马媛媛,葛庆华,丁存刚,周臻,李雪宁..拉米夫定片人体生物等效性评价[J].中国临床药学杂志,2013,22(2):86-90,5.
