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건일로딘 캡슐(에토돌락 200mg)에 대한 에토딘 캡슐의 생물학적동등성
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  • 건일로딘 캡슐(에토돌락 200mg)에 대한 에토딘 캡슐의 생물학적동등성
저자명
이명재,장종민,최상준,이진성,탁성권,서지형,류재환,임성빈,이경태,Lee. Myung-Jae,Kang. Jong-Min,Choi. Sang-Jun,Lee. Jin-Sung,Tak. Sung-Kwon,Seo. Ji-Hyung,Rew.
간행물명
藥劑學會誌
권/호정보
2008년|38권 6호|pp.421-427 (7 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 etodolac capsules, Kuhnillodin capsule (Kuhnil. Co., Ltd., Seoul, Korea) as reference drug and Etodin capsule (Myungmun Pharm. Co., Ltd., Seoul, Korea) as test drug, according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-three healthy male Korean volunteers received one capsule at the dose of 200 mg etodolac in a $2{ imes}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of etodolac were monitored by a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) for over a period of 24 hr after the administration. $AUC_{0-24;hr}$ was calculated by the linear trapezoidal rule method. $C_{max}$ and $T_{max}$ were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed $AUC_{0-24;hr}$ and $C_{max}$. The 90% confidence intervals of the $AUC_{0-24;hr}$ ratio and the $C_{max}$ ratio for Etodin/Kuhnillodin were $log;0.97{sim}log;1.08$ and $log;0.89{sim}log;1.19$, respectively. These values were within the acceptable bioequivalence intervals of $log;0.80{sim}log;1.25$. Thus, our study demonstrated that Etodin was bioeqiovalent to Kuhnillodin preparation when the rate and extent of absorption between two preparations were compared.