BIOEQUIVALENCE STUDY OF TWO FORMULATIONS OF 30 MG PIOGLITAZONE TABLETS IN HEALTHY THAI VOLUNTEERS

Rationale Generic pioglitazone tablets are available for treatment of type 2 diabetes. Bioequivalence study is used to compare bioavailability between the generic and original products. Objective To compare bioavailability of the new generic product: 30 mg oral pioglitazone tablets (Piotazone ® ), with the original product (Actos ® ). Materials and methods A randomized, single dose, two-sequence crossover design under fasting condition, with a minimum of 7 days washout period, was conducted in 24 healthy Thai volunteers. They received a 30 mg pioglitazone tablet of both generic and original formulations. Blood samples were collected over a period of 48 h after oral administration. Pioglitazone plasma concentrations were quantifi ed using a validated liquid chromatography with tandem mass spectrometry (LCMS/MS). All of the pharmacokinetic parameters were investigated using the non-compartmental analysis model. Results The 90% confi dence interval (CI) of the geometric mean ratio of Cmax, AUC0-t and AUC0-∞ in this study were within the equivalence criteria (80.00-125.00%), which were 95.72% (83.86%-109.25%), 101.73% (91.84%-112.68%) and 103.67% (92.40%-116.31%). No signifi cant differences of Tmax between the two formulations were observed (p>0.05). Both preparations were well tolerated and had few non-serious adverse events. Conclusion Pioglitazone from both tablet formulations was bioequivalent in terms of both rate and