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KMID : 0369820080380060421
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Jorunal of Korean Pharmaceutical Sciences
2008 Volume.38 No. 6 p.421 ~ p.427
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Bioequivalence of Etodin Capsule to Kuhnillodin Capsule (Etodolac 200 mg)
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Lee Myung-Jae
Lee Kyung-Tae
Seo Ji-Hyung
Choi Sang-Jun
Lee Jin-Sung
Kang Jong-Min
Tak Sung-Kwon
Rew Jae-Hwan
Yim Sung-Vin
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Abstract
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The purpose of the present study was to evaluate the bioequivalence of two etodolac capsules, Kuhnillodin capsule (Kuhnil. Co., Ltd., Seoul, Korea) as reference drug and Etodin capsule (Myungmun Pharm. Co., Ltd., Seoul, Korea) as test drug, according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-three healthy male Korean volunteers received one capsule at the dose of 200 mg etodolac in a 2×2 crossover study. There was a one-week ashout period between the doses. Plasma concentrations of etodolac were monitored by a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) for over a period of 24 hr after the administration. AUC0-24 hr was calculated by the linear trapezoidal rule method. Cmax and Tmax were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed AUC0-24 hr and Cmax. The 90% confidence intervals of the AUC0-24 hr ratio and the Cmax ratio for Etodin /Kuhnillodin were log 0.97 ~ log 1.08 and log 0.89 ~ log 1.19, respectively. These values were within the acceptable bioequivalence intervals of log 0.80 ~ log 1.25. Thus, our study demonstrated that Etodin was bioeqiovalent to Kuhnillodin preparation when the rate and extent of absorption etween two preparations were compared.
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KEYWORD
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Etodolac, LC-MS/MS, Bioequivalence
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