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KMID : 0369820010310040281
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Jorunal of Korean Pharmaceutical Sciences
2001 Volume.31 No. 4 p.281 ~ p.287
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조혜영/Cho HY
정현철/문재동/오인준/이용복/Jeong HC/Moon JD/Oh IJ/Lee YB
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Abstract
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Rebamipide is a novel anti-gastric ulcer agent that has been reported to increase the synthesis of mucus, to increase the mucosal concentration of prostaglandin, and to promote rapid ulcer healing. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, MucostaTM (Otsuka Korea Pharmaceutical Co., Ltd.) and RebamideTM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The rebamipide release from the two rebamipide tablets in vitro was tested using KP VII Apparatus II method at pH 6.8 dissolution media. Twenty normal male volunteers, 24.20±2.26 years in age and 66.19±9.41kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 100 mg of rebamipide was orally administered, blood was taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two rebamipide tablets were very similar at pH 6.8 dissolution media. Besides, the pharmacokinetic parameters such as AUCt, CmaxandTmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUCt, CmaxandTmax between two tablets based on the MucostaTM were -2.57%, 5.77% and -1.47%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1?β=0.8 were less than 20% (e.g., 12.62% and 17.63% for AUCt,andCmax, respectively). The powers (1?β) at α=0.05, Δ=0.2 for AUCtandCmax were above 99.00% and 88.56%, respectively. The 90% confidence intervals were within ±20 (e.g., ?9.96∼4.82 and ?4.54∼16.09 for AUCtandCmax, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that RebamideTM tablet is bioequivalent to MucostaTM tablet.
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KEYWORD
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Rebamipide, MucostaTM, RebamideTM, Bioequivalence, HPLC
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