Bioequivalence Study of 30 mg Pioglitazone Tablets in Thai Healthy Volunteers
Somruedee Chatsiricharoenkul MD*, Piyapat Pongnarin MSc*, Korbtham Sathirakul PhD**, Supornchai Kongpattanakul MD*
Affiliation : * Department of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol University ** Department of Pharmacy, Faculty of Pharmacy, Mahidol University
Objective : To compare the bioequivalent parameters of 30 mg pioglitazone tablets manufactured locally
(Glista®) and originally (Actos®).
Materials and Methods : 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
Cmax (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.
Keywords : Pioglitazone, Bioequivalence
