|
KMID : 0369820090390020133
|
|
Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 2 p.133 ~ p.139
|
|
|
Bioequivalence of Tablets to Tablets (Pioglitazone HCl 15 mg)
|
|
Kang Jong-Min
Lee Myung-Jae
Seo Ji-Hyung
Choi Sang-Jun
Lee Jin-Sung
Ryu Ju-Hee
Tak Sung-Kwon
Yim Sung-Vin
Hong Seung-Jae
Lee Kyung-Tae
|
|
|
Abstract
|
|
|
|
The purpose of the present study was to evaluate the bioequivalence of two pioglitazone HCl tablets, , tablets (Lilly Korea. Ltd., Korea) as a reference drug and , tablets (Reyon Pharm. Co., Ltd., Korea) as test drug, according to the guideline of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet containing pioglitazone HCl 15 mg in a crossover study. There was a one-week washout period between the doses. Plasma concentrations of pioglitazone were monitored for over a period of 36 hr after administration by using a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The area under the plasma concentration-time curve from time zero to 36 hr (), maximum plasma drug concentration () and time to reach () were complied from the plasma concentration-time data. Analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed and . The 90% confidence intervals of the ratio and the ratio for /. were log 0.8753-log 1.1286 and log 0.8669-log 1.1734, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25, recommended by KFDA. In all of these results, we concluded that the . tablet was bioequivalent to the . tablet, based on the rate and extent of absorption.
|
|
|
KEYWORD
|
|
|
Pioglitazone, LC-MS/MS, Bioequivalence
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|