LC-MS/MS를 이용한 제일크라비트정(레보플록사신 100 mg)에 대한 레사신정 100 mg의 생물학적 동등성 (Bioequivalence of LesacinTM Tablet to Jeil CravitTM Tablet (Levofloxacin 100 mg)by Liquid Chromatography- Electrospray Tandem Mass Spectrometry)

서지정보

· 발행기관 : 한국약제학회
· 수록지 정보 : Journal of Pharmaceutical Investigation / 38권 / 4호 / 269 ~ 275페이지
· 저자명 : 이경태, 이진성, 최상준, 류주희, 서지형, 이명재, 강종민, 탁성권, 강진양

초록

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 LesacinTM 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 2×2 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 (AUCt), maximum plasma drug concentration (Cmax) and time to reach Cmax (Tmax) 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 AUCt and Cmax. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for LesacinTM/Jeil CravitTM were log 0.9527 ~ log 0.9981 and log 0.8712 ~ log 1.0556, respectively. These values were within the acceptable bioequivalence intervals of log 0.80 ~ log 1.25, recommended by KFDA. In all of these
results, we concluded that LesacinTM tablet was bioequivalent to Jeil CravitTM tablet, in terms of rate and extent of absorption.

영어초록

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 LesacinTM 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 2×2 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 (AUCt), maximum plasma drug concentration (Cmax) and time to reach Cmax (Tmax) 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 AUCt and Cmax. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for LesacinTM/Jeil CravitTM were log 0.9527 ~ log 0.9981 and log 0.8712 ~ log 1.0556, respectively. These values were within the acceptable bioequivalence intervals of log 0.80 ~ log 1.25, recommended by KFDA. In all of these
results, we concluded that LesacinTM tablet was bioequivalent to Jeil CravitTM tablet, in terms of rate and extent of absorption.

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