18.97.9.171
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단보 : 건일로딘 정(미결정에토돌락 200 mg)에 대한 에토돌 정의 생물학적 동등성
Notes : Bioequivalence of Etodol(TM) Tablet to Kuhnillodine(TM) Tablet (Micronized Etodolac 200 mg)
이정애 ( Jung Ae Lee ) , 이윤영 ( Yun Young Lee ) , 조태섭 ( Tae Seob Cho ) , 박영준 ( Young Joon Park ) , 문병석 ( Byoung Seok Moon ) , 김호현 ( Ho Hyun Kim ) , 이예리 ( Ye Rie Lee ) , 이희주 ( Hee Joo Lee ) , 이경률 ( Kyung Ryul Lee )
UCI I410-ECN-0102-2009-510-002607460

A bioequivalence of Etodol™ tablets (Yuhan corporation) and Kuhnillodine™ tablets (Kuhnil Pharm, Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 ㎎ dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a 2×2 cross-over 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. C_(max) (maximum plasma drug concentration) and T_(max) (time to reach C_(max)) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed AUCt and C_(max). No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the AUCt ratio and the C_(max) ratio for Etodol™/Kuhnillodine™ were 1.01 - 1.10 and 0.87 - 1.06, respectively. This study demonstrated a bioequivalence of Etodol™ and Kuhnillodine™ with respect to the rate and extent of absorption.

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