Study on bioequivalence of pioglitazone hydrochloride tablets in healthy Chinese volunteers

摘要

This study was to investigate the pharmacokinetics of pioglitazone after a single oral dose ofpioglitazone hydrochloride tablets in healthy Chinese volunteers and to evaluate the bioequivalence between the test and the reference tablets. Methods Twenty healthy Chinese volunteers received a single oral dose of 30mg pioglitazone either as test or as reference tablet in a randomized, open label, two-way crossover study. Pioglitazone in human plasma was determined by a HPLC method. Results Mean maximum concentration (C_(max)) of pioglitazone was 1.85 mgcentre notL~(-1) at 1.8 hours for test tablets and 1.86mgcentre notL~(-1) at 1.9 hours for reference tablets. Mean area under the plasma concentration-time curve from zero to last measured point (AUC_(0-t)) for test was 15.51mgcentre nothcentre notL~(-1) compared with 15.37 mgcentre nothcentre notL~(-1) for reference. The analysis of variance on C_(max) and AUC indicated that there was no significant difference between the two formulations. All 90% confidence intervals (CIs) of the test/reference geometric mean ratio were within the bioequivalence limits. Conclusion The test tablets were bioequivalent with the reference tablets.