Publication: Bioequivalence study of 30 mg pioglitazone tablets in Thai healthy volunteers
Issued Date
2007-03-01
Resource Type
ISSN
01252208
01252208
01252208
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2-s2.0-33947275065
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Mahidol University
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SCOPUS
Bibliographic Citation
Journal of the Medical Association of Thailand. Vol.90, No.3 (2007), 564-568
Suggested Citation
Somruedee Chatsiricharoenkul, Piyapat Pongnarin, Korbtham Sathirakul, Supornchai Kongpattanakul Bioequivalence study of 30 mg pioglitazone tablets in Thai healthy volunteers. Journal of the Medical Association of Thailand. Vol.90, No.3 (2007), 564-568. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/24950
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Title
Bioequivalence study of 30 mg pioglitazone tablets in Thai healthy volunteers
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Abstract
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%), 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.