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KCI 등재 SCOPUS
뮤코펙트 정(염산암브록솔 30mg)에 대한 암브렉트 정의 생물학적 동등성
Bioequivalence of Ambrect(TM) Tablet to Mucopect(TM) Tablet (Ambroxol hydrochloride 30 mg)
유정연 ( Yu Jeong Yeon ) , 정선경 ( Jeong Seon Gyeong ) , 최미희 ( Choe Mi Hui ) , 한상범 ( Han Sang Beom ) , 이경률 ( Lee Gyeong Lyul ) , 이희주 ( Lee Hui Ju )
약제학회지 33권 3호 215-221(7pages)
UCI I410-ECN-0102-2009-510-003332975

A bioequivalence study of Ambrect^(™) tablets (Dong Wha Pharm. Ind. Co., Ltd.) to Mucopect^(™) tablets(Boe-hringer Ingelheim Korea, Ltd.) was conducted according to the guideline of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the ambroxol hydorchoride dose of 30 ㎎ in a 2×2 crossover study. There was a one-week wash out period between the doses. Plasma concentrations of ambroxol were monitored by a high-performance liquid chromatography for over a period of 24 hours after the administration. Aug_(t)(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 compilied from the plasma concentraction-time data. Analysis of variance was carried out using logarithmically transformed AUC_(T) and C_(max). No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the AUC_(t) ratio and the C_(max) ratio for Ambrect^(™)/Mucopect^(™) were 0.89-1.01 and 0.89-1.02, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstarated the bioequivalence of Ambrect^(™) and Mucopect^(™) with respect to the rate and extent of absorption.

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