Bioequivalence study of 30 mg pioglitazone tablets in Thai healthy volunteers.
Article
in English
| IMSEAR
| ID: sea-42243
ABSTRACT
OBJECTIVE:
To compare the bioequivalent parameters of 30 mg pioglitazone tablets manufactured locally (Glista) and originally (Actos). MATERIAL ANDMETHOD:
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.CONCLUSION:
The 2-tablet preparations of pioglitazone were bioequivalent in Thai healthy volunteers.
Full text:
Available
Index:
IMSEAR (South-East Asia)
Main subject:
Tablets
/
Thailand
/
Female
/
Humans
/
Male
/
Therapeutic Equivalency
/
Adolescent
/
Cross-Over Studies
/
Adult
/
Thiazolidinediones
Type of study:
Controlled clinical trial
Country/Region as subject:
Asia
Language:
English
Year:
2007
Type:
Article
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