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KMID : 0369820080380040269
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Jorunal of Korean Pharmaceutical Sciences
2008 Volume.38 No. 4 p.269 ~ p.275
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Bioequivalence of Lesacin™ Tablet to Jeil Cravit™ Tablet (Levofloxacin 100 mg) by Liquid Chromatography- Electrospray Tandem Mass Spectrometry
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Lee Jin-Sung
Choi Sang-Jun
Ryu Ju-Hee
Seo Ji-Hyung
Lee Myung-Jae
Kang Jong-Min
Tak Sung-Kwon
Kang Chin-Yang
Lee Kyung-Tae
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Abstract
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The purpose of the present study was to evaluate the bioequivalence of two levofloxacin tablets, Jeil tablet (Jeil Pharm. Co., Ltd., Korea, reference drug) and 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 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 (), maximum plasma drug concentration () and time to reach 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 and . The 90% confidence intervals of the ratio and the ratio for /Jeil were and , respectively. These values were within the acceptable bioequivalence intervals of , recommended by KFDA. In all of these results, we concluded that tablet was bioequivalent to Jeil tablet, in terms of rate and extent of absorption.
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KEYWORD
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Levofloxacin, LC-MS/MS, Bioequivalence, Analytical validation
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