Sualeha Riffat
Pakistan
Research Article
Bioequivalence Evaluation of a Combine Formulation of Pioglitazone/
Metformin in Healthy Pakistani Volunteers
Author(s): Mateen Abbas, Sualeha Riffat, Abdul Muqeet Khan and Muhammad NawazMateen Abbas, Sualeha Riffat, Abdul Muqeet Khan and Muhammad Nawaz
The purpose of this study was to evaluate bioequivalence of a combine formulation of pioglitazone/metformin 15/850 mg tablet with those of an established branded formulation. An open-label, single-dose, randomized, 2-way crossover study was conducted in fasted healthy Pakistani male volunteers. The concentrations of pioglitazone and metformin in plasma were analyzed by reverse phase High Performance Liquid Chromatography (HPLC). The plasma concentration-time curves were used to obtain pharmacokinetic parameters including AUC 0-t , AUC 0-∞ , and C max . The formulations were considered bioequivalent if the 90% confidence intervals (CIs) for AUC, and C max fell within the interval of 80% to 125%, declared in bioequivalence guidelines. On analysis of variance, no period, formulation or sequence effects were observed for any pharmacokinetic property. The 90% confidence intervals of .. View More»
DOI:
10.4172/jbb.1000066