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KMID : 0369820040340040319
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Jorunal of Korean Pharmaceutical Sciences
2004 Volume.34 No. 4 p.319 ~ p.325
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Bioequivalence of Etodol(TM) Tablet to Kuhnillodine(TM) Tablet (Micronized Etodolac 200 mg)
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이정애/Lee JA
이윤영/조태섭/박영준/문병석/김호현/이예리/이희주/이경률/Lee YY/Cho TS/Park YJ/Moon BS/Kim HH/Lee YR/Lee HJ/Lee KR
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Abstract
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A bioequivalence of EtodolTM tablets (Yuhan corporation) and KuhnillodineTM tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a 2×2 crossover design. Concentrations of etodolac in human plasma were monitored by a high-performance liquid chromatography. AUCt (the area under the plasma concentration-time curve from time zero to 24 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 performed using logarithmically transformed AUCt and Cmax. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for EtodolTM/KuhnillodineTM were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of EtodolTM and KuhnillodineTM with respect to the rate and extent of absorption.
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KEYWORD
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Etodolac, Kuhnillodine(TM), Etodol(TM), Bioequivalence, HPLC
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