2006•Unpublished venueRequires access
Research on Bioequivalence of Telmisartan Tablets in Healthy Volunteers
Hou Fei-yan, Zhi Li
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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 imˉported tablets were(540.7±314.1)μg/L,(1.3±0.6)h,(3138.1±2124.7)(μg·h)/L,(21.3±6.6)h,respectively,while the same parameters of the domestic tablets were(534.2±314.3)μg/L,(1.3±0.8)h,(3038.1±1997.9)(μg·h)/L,and(20.7±5.3)h,respectively.The relative bioavailability of domestic tablets was(100.0±13.9)%.CONCLUSION:Domestic telmisˉartan tablets and imported ones have bioequivalence.