Bioequivalence study of 30 mg pioglitazone tablets in Thai healthy volunteers
Chatsiricharoenkul, S.; Pongnarin, P.; Sathirakul, K.; Kongpattanakul, S.
Journal of the Medical Association of Thailand 90(3): 564-568
2007
ISSN/ISBN: 0125-2208 PMID: 17427536 Document Number: 2808
Objective: To compare the bioequivalent parameters of 30 mg pioglitazone tablets manufactured locally (Glista (R)) and originally (Actos (R)).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-MSIMS).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 -> l)(85.7139-114.2861%) and AUC(0 ->infinity) (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.
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