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서지반출
토파맥스 정(토피라메이트 100mg)에 대한 토파민 정의 생물학적동등성
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  • 토파맥스 정(토피라메이트 100mg)에 대한 토파민 정의 생물학적동등성
저자명
서지형,이명재,최상준,강종민,이진성,탁성권,이경태,Seo. Ji-Hyung,Lee. Myung-Jae,Choi. Sang-Jun,Kang. Jong-Min,Lee. Jin-Sung,Tak. Sung-Kwon,Lee. Kyung-T
간행물명
藥劑學會誌
권/호정보
2008년|38권 4호|pp.277-282 (6 pages)
발행정보
한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The purpose of the present study was to evaluate the bioequivalence of two topiramate tablets, Topamax tablet (Janssen Korea. Co., Ltd., Seoul, Korea, reference drug) and Topamin tablet (Myungmoon Pharm. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet at the dose of 100 mg topiramate in a $2{ imes}2$ crossover study. There were two-weeks washout period between the doses. Plasma concentrations of topiramate were monitored by an LC-MS/MS for over a period of 96 hr after administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 96 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals of the $AUC_t$, ratio and the $C_{max}$ ratio for Topamin/Topamax were $log0.88{sim}log1.02$ and $log0.87{sim}log1.03$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{sim}log1.25$. Taken together, our study demonstrated the bioequivalence of Topamax and Topamin with respect to the rate and extent of absorption.