Bioequivalence study of 30 mg pioglitazone tablets in Thai healthy volunteers

Abstract

Objective: To compare the bioequivalent parameters of 30 mg pioglitazone tablets manufactured locally (Glista®) and originally (Actos®). Material and Method: A randomized, single dose, two-treatment, two-period, two-sequence crossover study was conducted. Twenty-four healthy volunteers were recruited at Siriraj Clinical Research Unit. Each subject received a 30 mg pioglitazone tablet of both formulations with at least a week washout period. Blood samples were collected over 48 h after the oral administration. The plasma fractions were analyzed for pioglitazone using a liquid chomatography-mass spectrometry (LC-MS/MS). Results: Twenty-four volunteers enrolled in the present study. Pharmacokinetic parameters were determined using the non-compartment model. The 90 percent confidence intervals of the mean ratios (test/reference) of C max (86.2687-113.7313%), AUC0 → t(85.7139-114.2861%) and AUC0 → ∞ (81.7820-118.2180%) fell within the acceptable range (80-125%) for bioequivalent eligibility. Both preparations were well tolerated and had a few non-serious adverse events. Conclusion: The 2-tablet preparations of pioglitazone were bioequivalent in Thai healthy volunteers.