富马酸替诺福韦二吡呋酯片在健康人体的生物等效性研究

发布时间：2018-04-08 14:16

  本文选题：富马酸替诺福韦二吡呋酯片　切入点：生物等效性　出处：《中国临床药理学杂志》2016年23期

【摘要】：目的评价富马酸替诺福韦二吡呋酯片在健康人体的生物等效性。方法 22例健康男性受试者随机分成2组,采用随机、开放、双周期自身交叉试验。单剂量口服富马酸替诺福韦二吡呋酯片受试药品和参比药品300 mg,用LC-MS/MS测定血浆中药物浓度,药代动力学参数用DAS 2.1.1软件处理获得。结果受试药品与参比药品的Cmax分别为(281.04±84.77)和(283.86±80.71)ng·mL~(-1),tmax分别为(1.02±0.44)和(0.90±0.41)h,AUC0-t分别为(2351.80±518.1),(2338.98±524.99)ng·h·mL~(-1),AUC0-∞分别为(2574.25±581.07),(2571.42±574.43)ng·h·mL~(-1),相对于参比药品,受试药品的生物利用度F0-t为(102.11±19.76)%。试验期间未发生严重不良事件。结论富马酸替诺福韦二吡呋酯片受试药品和参比药品具有生物等效性。
[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.缁撴灉鍙楄瘯鑽�鍝佷笌鍙傛瘮鑽�鍝佺殑Cmax鍒嗗埆涓，

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