中国临床药理学杂志2024，Vol.40Issue(2)：249-253,5.DOI:10.13699/j.cnki.1001-6821.2024.02.020
替米沙坦片在中国健康受试者的生物等效性研究
Bioequivalence study of telmisartan tablets in Chinese healthy subjects
摘要
Abstract
Objective To evaluation the bioequivalence of telmisartan tablets(80 mg)between test formulation and reference formulation in Chinese healthy subjects.Methods A single-center,randomized,open-label,two-preparations,single administration,partial repeat crossover of three sequences in three postprandial cycles and complete repeat crossover of two sequences in four fasting cycles,bioequivalence test was designed.Chinese healthy subjects were included in the bioequivalence trial,with 33 randomly assigned to the postprandial group and 32 randomly assigned to the fasting group.In each period,blood samples was collected before and after administration.The plasma concentration of the drug was determined by LC-MS/MS,using WinNonlin version 8.3 calculate the pharmacokinetic parameters and perform a statistical analysis using SAS version 9.4.Results The main pharmacokinetic parameters of telmisartan tablets after oral administration of test or reference were as follows.Fasting group Cmax were(556.10±456.06)and(580.99±533.50)ng·mL-1;AUC0-t were(3 475.15±3 785.16)and(3 450.54±3 681.02)ng·mL-1·h;AUC0-∞ were(3 214.06±2 272.06)and(3 194.84±2 187.45)ng·mL-1·h.The 90％confidence intervals of the geometric mean ratio of Cmax,AUC0-t,AUC0-∞ were within the requirements of the equivalent range of bioequivalence(80.00％-125.00％).Postprandial group Cmax were(299.26±124.72)and(291.29±126.34)ng·mL-1;AUC0-t were(3 682.24±2 799.72)and(3 636.71±2 158.42)ng·mL-1·h;AUC0-were(3 544.53±1 553.06)and(3 969.38±2 528.22)ng·mL-1·h.The 90％confidence intervals of the geometric mean ratio of Cmax,AUC0-t,AUC0-∞ were within the requirements of the equivalent range of bioequivalence(80.00％-125.00％).Conclusion Under fasting and fed conditions,two kinds of telmisartan tablets are bioequivalent in Chinese healthy subjects.关键词
替米沙坦片/生物等效性/药代动力学参数Key words
telmisartan tablets/bioequivalence/pharmacokinetic parameters分类
医药卫生引用本文复制引用
孙成,张燕,房红霞,陈桂英,章晓娟,孙洪勋,姜彬..替米沙坦片在中国健康受试者的生物等效性研究[J].中国临床药理学杂志,2024,40(2):249-253,5.基金项目
淄博万杰制药有限公司和南京迈迪信泽医药科技开发有限公司委托研发课题基金资助项目 （）
