Comparative Pharmacokinetics and Bioequivalence Assessment of Metformin/Pioglitazone Tablet in Fasting and Fed Conditions: A Randomized Study in Healthy Chinese Subjects
Abstract
Metformin/pioglitazone tablets are a fixed-dose combination of metformin hydrochloride and pioglitazone. In healthy Chinese subjects, this study evaluated the pharmacokinetics and bioequivalence of metformin/pioglitazone (500/15 mg) tablets. We conducted a single-center, open-label, randomized, two-way crossover study in which subjects were randomized in a 1:1 ratio to either the test formulation or the reference formulation, separated by a 10-day washout period. Blood samples collected at pre-arranged intervals before and after dosing were analyzed using validated liquid chromatography-tandem mass spectrometry techniques to determine metformin and pioglitazone plasma concentrations. Finally, subjects completed fasting and fed studies, respectively. In both studies, the 90% confidence intervals for the geometric mean ratios (test/reference) of Cmax, AUC0-t, and AUC0-∞ were within acceptable bioequivalence limits (0.80-1.25), and no serious adverse events were observed. The study demonstrated that the tested and reference formulations of metformin/pioglitazone tablets are bioequivalent and well tolerated under both fasting and fed conditions.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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