Abstract
This study aimed to compare the bioavailability of two 10-mg Imidapril HCl tablet formulations using TENSIMID® as the test formulation and TANAPRESS® as the reference formulation. Twenty-seven healthy subjects completed a single-dosed, open-label, randomized, two-way crossover bioequivalence study under overnight fasting condition with one week wash-out period. The blood samples were collected from the subjects prior to administration and up to 12 hours after dosing. Plasma concentrations of imidapril were determined using LC-MS/MS method with TurboIon Spray mode. Pharmacokinetic parameters of AUC0-t, AUC0-∞and Cmax were tested for bioequivalence after log-transformation of data and ratios of tmax was evaluated non-parametrically. The estimated points and 90% confidence interval (CI) for AUC0-t, AUC0-∞and Cmax of imidapril were 93.04% (82.63-104.76%), 93.12% (82.84-104.67%), and 94.00% (80.96-109.14%), respectively. There was no statistically significant difference of tmax and t1/2 detected in both formulations (p
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