Research on Bioequivalence of Telmisartan Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the bioequivalence of domestic telmisartan tablets and imported ones.METHODS:20volunteers were randomly divided into2groups(domestic and imported).A single oral dose of80mg telmisartan were given to each volunteer in the open random crossover study.Telmisartan serum concentrations were determined by HPLC-MS.Pharmacokinetic parameters and relative bioavailability were calculated.RESULTS:C max 、t max 、AUC 0～96 and t 1/2 of the im?ported tablets were(540.7?314.1)?g/L,(1.3?0.6)h,(3138.1?2124.7)(?g?h)/L,(21.3?6.6)h,respectively,while the same parameters of the domestic tablets were(534.2?314.3)?g/L,(1.3?0.8)h,(3038.1?1997.9)(?g?h)/L,and(20.7?5.3)h,respectively.The relative bioavailability of domestic tablets was(100.0?13.9)%.CONCLUSION:Domestic telmis?artan tablets and imported ones have bioequivalence.