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KMID : 0369820060360020131
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Jorunal of Korean Pharmaceutical Sciences
2006 Volume.36 No. 2 p.131 ~ p.136
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Bioequivalence of Losartan(TM) Tablet to Cozzar(TM) Tablet (Losartan Kalium 50mg)
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김용원/Kim YW
박완수/김성수/서지형/조성희/이헌우/류재환/이경태/Park WS/Kim SS/Seo JH/Cho SH/Lee HW/Rew JH/Lee KT
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Abstract
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The purpose of the present study was to evaluate the bioequivalence of two losartan tablets, CozaarTM tablet (MSD Korea. Co., Ltd., Seoul, Korea, reference drug) and LosartanTM 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\time2 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. AUCt (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCt and Cmax. 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 AUCt ratio and the Cmax ratio for CozaarTM/LosartanTM were log0.97∼log1.12andlog0.93∼log1.23, respectively. These values were within the acceptable bioequivalence intervals of log0.80∼log1.25. Taken together, our study demonstrated the bioequivalence of CozaarTM and LosartanTM with respect to the rate and extent of absorption.
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KEYWORD
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Losartan, LC-MS/MS, Bioequivalence
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