Study on the pharmacokinetics and relative bioavailability of irbesartan capsules in healthy volunteers

Summary

The pharmacokinetics and relative bioavailability were studied in 18 healthy volunteers. A single oral dose of 150 mg irbesartan capsule (test) or tablet (reference) was given to each volunteer according to a randomized 2-way crossover study. The concentrations in plasma were determined by HPLC-UV method. The main parameters of irbesartan capsules were: C_max: 1.502±0.295 μg/ml, t_max: 1.44±0.34 h, t_1/2: 20.21±14.71 h, AUC_0−t; 11.087±3.443 μg/ml⁻¹·h. The relative bioavailability of capsule to tablet was (101.4±28.9)%. The results of statistical analysis showed that two formulations were bioequivalent.