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LC-MS/MS를 이용한 제일크라비트정(레보플록사신 100 mg)에 대한 레사신정 100 mg의 생물학적 동등성
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  • LC-MS/MS를 이용한 제일크라비트정(레보플록사신 100 mg)에 대한 레사신정 100 mg의 생물학적 동등성
저자명
이진성,최상준,류주희,서지형,이명재,강종민,탁성권,강진양,이경태,Lee. Jin-Sung,Choi. Sang-Jun,Ryu. Ju-Hee,Seo. Ji-Hyung,Lee. Myung-Jae,Kang. Jong-Min,Tak. Su
간행물명
藥劑學會誌
권/호정보
2008년|38권 4호|pp.269-275 (7 pages)
발행정보
한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The purpose of the present study was to evaluate the bioequivalence of two levofloxacin tablets, Jeil $Cravit^{TM}$ tablet (Jeil Pharm. Co., Ltd., Korea, reference drug) and $Lesacin^{TM}$ tablet (Ilhwa. 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 containing levofloxacin 200 mg in a $2{ imes}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of levofloxacin were monitored for over a period of 24 hr after administration by using a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The area under the plasma concentration-time curve from time zero to 24 hr ($AUC_t$), maximum plasma drug concentration ($C_{max}$) and time to reach $C_{max};(T_{max})$ were complied 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 $AUC_t$ ratio and the $C_{max}$ ratio for $Lesacin^{TM}$/Jeil $Cravit^{TM}$ were $log;0.9527{sim}log;0.9981$ and $log;0.8712{sim}log;1.0556$, respectively. These values were within the acceptable bioequivalence intervals of $log;0.80{sim}log;1.25$, recommended by KFDA. In all of these results, we concluded that $Lesacin^{TM}$ tablet was bioequivalent to Jeil $Cravit^{TM}$ tablet, in terms of rate and extent of absorption.