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KMID : 0369820090390060457
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Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 6 p.457 ~ p.463
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Bioequivalence of MeloxifenTM Capsule to MobicTM Capsule(Meloxicam 7.5 mg)
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Lee Jin-Sung
Tak Sung-Kwon
Seo Ji-Hyung
Kang Jong-Min
Ryu Ju-Hee
Yim Sung-Vin
Hong Seung-Jae
Lee Kyung-Tae
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Abstract
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The purpose of the present study was to evaluate the bioequivalence of meloxicam capsule, MobicTM capsule( Boehringer Ingelheim Ltd., Korea) as a reference drug and MeloxifenTM capsule (Kukje Pharma Ind. Co., Ltd., Korea) as a test drug, according to the guidelines of Korea Food and Drug Administration(KFDA). Thirty two healthy male Korean volunteers received capsule containing meloxicam 7.5 mg in a 2×2 crossover study. There was a one-week above washout period between the doses. Plasma concentrations of meloxicam were monitored for over a period of 72 hr after administration by using a high performance liquid chromatography-tandem mass spectrometer(LC-MS/MS). AUCt(the area under the plasma concentration-time curve from time zero to 72 hr), Cmax(maximum plasma drug concentration) and Tmax(time to reach Cmax) 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 MeloxifenTM/MobicTM were log 0.8605-log 0.9847 and log 0.9765-log 1.1503, 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 MeloxifenTM capsule was bioequivalent to MobicTM capsule, based on the rate and extent of absorption.
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KEYWORD
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Meloxicam, LC-MS/MS, Bioequivalence
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