Bioequivalence of MeloxifenTM Capsule to MobicTM Capsule(Meloxicam 7.5 mg)

The purpose of the present study was to evaluate the bioequivalence of meloxicam capsule, capsule( Boehringer Ingelheim Ltd., Korea) as a reference drug and 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 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). (the area under the plasma concentration-time curve from time zero to 72 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 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 capsule was bioequivalent to capsule, based on the rate and extent of absorption.