中国临床药理学杂志2024，Vol.40Issue(9)：1311-1315,5.DOI:10.13699/j.cnki.1001-6821.2024.09.015
恩替卡韦片在中国健康受试者空腹状态下的生物等效性研究
Bioequivalence study of entecavir tablets in healthy Chinese subjects under fasting condition
摘要
Abstract
Objective To evaluate the pharmacokinetics and bioequivalence of two entecavir tablets under fasting condition in Chinese healthy volunteers.Methods A single oral dose of 0.50 mg entecavir test and reference formulations was given to 30 healthy volunteers in the fasting state according to two randomized open-label crossover clinical studies.Plasma concentrations were determined by HPLC-MS/MS after deproteinized with acetonitrile.The pharmacokinetic parameters were calculated by WinNonlin 6.4.The bioequivalence of entecavir tablets test and its reference in the fasting state were evaluated respectively.Results In the fasting state,the main pharmacokinetic parameters of entecavir were as follows:Cmax were(4 390.00±1 257.56)and(4 421.00±1 239.55)pg·mL-1;tmax were 0.67(0.33,2.00)and 0.75(0.50,2.00)h;t1/2were(29.71±14.50)and(35.43±16.58)h,AUC0_72h were(12 252.43±2 671.28)and(12 063.43±2 151.50)pg·mL-1·h.The 90％confidence intervals of the mean ratio of Cmax,AUC0-72h and AUC0-∞ of the text and reference formulations were all within the equivalent interval of 80.00％-125.00％.Conclusion The entecavir tablets test and its reference were bioequivalent in the fasting state.关键词
恩替卡韦/空腹/生物等效性/药代动力学/液相-串联质谱方法Key words
entecavir/fasting/bioequivalence/pharmacokinetics/high-performance liquid chromatography-tandem mass spectrometry分类
医药卫生引用本文复制引用
张娟,王蒙,黄明,王吉,张全英..恩替卡韦片在中国健康受试者空腹状态下的生物等效性研究[J].中国临床药理学杂志,2024,40(9):1311-1315,5.基金项目
江苏省药学会-奥赛康医院药学科研基金资助项目(A20225) （A20225）
