恩曲他滨丙酚替诺福韦片(Ⅱ)在中国健康成人中的生物等效性试验  

Bioequivalence tests of emtricitabine and tenofovir alafenamide fumarate tablets(Ⅱ) in healthy Chinese adults

作　　者：刘建芬 张向彬 王若毓 王彩肖 张颖 任风芝 米文强[2,3] LIU Jianfen;ZHANG Xiangbin;WANG Ruoyu;WANG Caixiao;ZHANG Ying;REN Fengzhi;MI Wenqiang(North China Pharmaceutical Huakun Hebei Biotechnology Co.,Ltd,Shijiazhuang 050000,China;不详)

机构地区：[1]华北制药华坤河北生物技术有限公司,石家庄市050000 [2]河北省多组分生化药物制备技术创新中心,石家庄市050000 [3]华北制药集团新药研究开发有限责任公司,石家庄市052165

出　　处：《临床合理用药杂志》2024年第17期1-5,共5页Chinese Journal of Clinical Rational Drug Use

基　　金：石家庄市科技计划项目(236200177A)。

摘　　要：目的 以国产恩曲他滨丙酚替诺福韦片(Ⅱ)为受试制剂,考察其与参比制剂在中国健康成人中的生物等效性及安全性。方法 按照入选标准各选取36例受试者分别进行空腹、餐后试验。给药采用单中心、随机、开放、三周期、三交叉、单剂量设计。受试者血浆中的活性药物成分为恩曲他滨和丙酚替诺福韦,采用液相色谱—串联质谱法测定规定采血点的血药浓度,分别计算受试制剂和参比制剂的主要药代动力学参数,使用统计学方法评价生物等效性和安全性。结果 受试制剂与参比制剂在中国健康成人体内的吸收速度与程度基本一致;单次口服给药在受试者中的暴露量和吸收程度相似;试验期间未发生严重不良事件/不良反应。结论 受试制剂与参比制剂在空腹和餐后给药条件下均符合生物等效性判定标准,且安全性相当。Objective To investigate the bioequivalence and safety of emtricitabine and tenofovir alafenamide fumarate tablets(Ⅱ) and its reference preparations in healthy Chinese adults.Methods According to the inclusion criteria,36 subjects were selected for fasting and postprandial tests respectively.The drug was administered in a single-center,randomized,open-label,three-cycle,three-cross,single-dose design.The active drug ingredients in the plasma of the subjects were emtricitabine and tenofovir alafenamide.The plasma drug concentrations at the specified blood sampling times were determined by liquid chromatography-tandem mass spectrometry.The main pharmacokinetic parameters of the tested preparation and the reference preparation were calculated respectively,and the bioequivalence and safety were evaluated by statistical methods.Results The absorption rate and degree of the tested preparation and the reference preparation in Chinese healthy adults are basically the same.The exposure and absorption of a single oral administration were similar in subjects;No serious adverse events/adverse reactions occurred during the trial.Conclusion The tested preparation and the reference preparation meet the criteria of bioequivalence under the conditions of fasting and postprandial administration,and the safety are comparable.

关 键 词：恩曲他滨丙酚替诺福韦片(Ⅱ) 液相色谱—串联质谱法 生物等效性 安全性 

分 类 号：R969[医药卫生—药理学]