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KMID : 0369820070370040249
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Jorunal of Korean Pharmaceutical Sciences
2007 Volume.37 No. 4 p.249 ~ p.254
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Bioequivalence of Taepyungyang Baclofen Tablet to Baclan(TM) Tablet (Baclofen 10mg)
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Kang Il-Mo
Lee Kyung-Tae
Kang Chin-Yang
Lee Heon-Woo
Lee Hyun-Soo
Seo Ji-Hyung
Ryu Ju-Hee
Lee Myung-Jae
Choi Sang-Jun
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Abstract
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The purpose of the present study was to evaluate the bioequivalence of two baclofen tablets, tablet (Yooyoung Pharm. Co., Ltd., Seoul, Korea, reference drug) and Taepyungyang Baclofen tablet (Pacificpharma Corporation, Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received three tablets containing baclofen 10 mg in a crossover study. There was a one-week washout period between the doses. Plasma concentrations of baclofen were monitored for over a period of 24 hr after the administration by using an LC-MS/MS. were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed . The 90% confidence intervals of the and the for Taepyungyang were , respectively. These values were within the acceptable bioequivalence intervals of . It was concluded that Taepyungyang Baclofen tablet was bioequivalent to tablet, in terms of both rate and extent of absorption.
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KEYWORD
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Baclofen, LC-MS/MS, Bioequivalence
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