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서지반출
바클란 정(바클로펜 10 mg)에 대한 태평양바클로펜 정의 생물학적동등성
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  • 바클란 정(바클로펜 10 mg)에 대한 태평양바클로펜 정의 생물학적동등성
저자명
강일모,류주희,이헌우,서지형,이현수,이명재,최상준,강진양,이경태,Kang. Il-Mo,Ryu. Ju-Hee,Lee. Heon-Woo,Seo. Ji-Hyung,Lee. Hyun-Soo,Lee. Myung-Jae,Choi. Sang-
간행물명
藥劑學會誌
권/호정보
2007년|37권 4호|pp.249-254 (6 pages)
발행정보
한국약제학회
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정기간행물|
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The purpose of the present study was to evaluate the bioequivalence of two baclofen tablets, $Baclan^{TM}$ 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 $2{ imes}2$ 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. $AUC_t,;C_{max};and;T_{max}$ 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 $AUC_t;and;C_{max}$. The 90% confidence intervals of the $AUC_t$ and the $C_{max}$ for Taepyungyang $Baclofen/Baclan^{TM}$ were $log0.92{sim}log1.06;and;log1.03{sim}log1.22$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{sim}log1.25$. It was concluded that Taepyungyang Baclofen tablet was bioequivalent to $Baclan^{TM}$ tablet, in terms of both rate and extent of absorption.