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코자 정(로자탄 칼륨 50 mg)에 대한 로자르탄 정의 생물학적동등성
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  • 코자 정(로자탄 칼륨 50 mg)에 대한 로자르탄 정의 생물학적동등성
저자명
김용원,박완수,김성수,서지형,조성희,이헌우,류재환,이경태,Kim. Yong-Won,Park. Wan-Su,Kim. Sung-Su,Seo. Ji-Hyung,Cho. Sung-Hee,Lee. Heon-Woo,Rew. Jae-Hwan,
간행물명
藥劑學會誌
권/호정보
2006년|36권 2호|pp.131-136 (6 pages)
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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 losartan tablets, $Cozaar^{TM}$ tablet (MSD Korea. Co., Ltd., Seoul, Korea, reference drug) and $Losartan^{TM}$ tablet (DaeWon Pharm. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets at the losartan kalium dose of 100 mg in a $2;{ ime};2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of losartan were monitored by an LC-MS/MS for over a period of 12 hr after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 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 was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Cozaar^{TM}/Losartan^{TM}$ were $log;0.97{sim}log;1.12;and;log;0.93{sim}log;1.23$, respectively. These values were within the acceptable bioequivalence intervals of $log;0.80{sim}log;1.25$. Taken together, our study demonstrated the bioequivalence of $Cozaar^{TM}$ and $Losartan^TM$ with respect to the rate and extent of absorption.