Bioequivalence study of 30 mg pioglitazone tablets in Thai healthy volunteers.
OBJECTIVE
To compare the bioequivalent parameters of 30 mg pioglitazone tablets manufactured locally (Glista) and originally (Actos).


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%), A UC0-->t(85. 7139-114.2861%) and AUC0-->infinity (81.7820-118.2180%) fell within the acceptable range (80-125%) for bioequivalent eligibility. Both preparations were well tolerated and had afew non-serious adverse events.


CONCLUSIONS
The 2-tablet preparations of pioglitazone were bioequivalent in Thai healthy volunteers.
Chatsiricharoenkul
Somruedee
S
Department of Pharmacology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand.
Pongnarin
Piyapat
P
Sathirakul
Korbtham
K
Kongpattanakul
Supornchai
S
D000293:Adolescent; D000328:Adult; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D000077205:Pioglitazone; D013607:Tablets; D013785:Thailand; D013810:Therapeutic Equivalency; D045162:Thiazolidinediones / Q000008:administration & dosage* / Q000493:pharmacokinetics*
D007004:Hypoglycemic Agents; D013607:Tablets; D045162:Thiazolidinediones; D000077205:Pioglitazone