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%), AUC_{0 → t} (85.7139-114.2861%) and AUC_{0 → ∞} (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.

Keywords: Pioglitazone, Bioequivalence