本文選題：富馬酸替諾福韋二吡呋酯片　切入點(diǎn)：生物等效性　出處：《中國(guó)臨床藥理學(xué)雜志》2016年23期

【摘要】：目的評(píng)價(jià)富馬酸替諾福韋二吡呋酯片在健康人體的生物等效性。方法 22例健康男性受試者隨機(jī)分成2組,采用隨機(jī)、開(kāi)放、雙周期自身交叉試驗(yàn)。單劑量口服富馬酸替諾福韋二吡呋酯片受試藥品和參比藥品300 mg,用LC-MS/MS測(cè)定血漿中藥物濃度,藥代動(dòng)力學(xué)參數(shù)用DAS 2.1.1軟件處理獲得。結(jié)果受試藥品與參比藥品的Cmax分別為(281.04±84.77)和(283.86±80.71)ng·mL~(-1),tmax分別為(1.02±0.44)和(0.90±0.41)h,AUC0-t分別為(2351.80±518.1),(2338.98±524.99)ng·h·mL~(-1),AUC0-∞分別為(2574.25±581.07),(2571.42±574.43)ng·h·mL~(-1),相對(duì)于參比藥品,受試藥品的生物利用度F0-t為(102.11±19.76)%。試驗(yàn)期間未發(fā)生嚴(yán)重不良事件。結(jié)論富馬酸替諾福韋二吡呋酯片受試藥品和參比藥品具有生物等效性。
[Abstract]:Objective to evaluate the bioequivalence of tenofovir dipyrifuroxime fumarate tablets in healthy volunteers.Methods 22 healthy male subjects were randomly divided into two groups.A single dose of tenofovir Fumarate dipyrifuroxime difuroxime fumarate tablets was taken orally. The plasma concentrations of the drugs were determined by LC-MS/MS. The pharmacokinetic parameters were obtained by DAS 2.1.1 software.緇撴灉鍙楄瘯鑽搧涓庡弬姣旇嵂鍝佺殑Cmax鍒嗗埆涓，

本文編號(hào)：1721978