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뮤코펙트 정(염산암브록솔 30 mg)에 대한 암브렉트 정의 생물학적 동등성
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  • 뮤코펙트 정(염산암브록솔 30 mg)에 대한 암브렉트 정의 생물학적 동등성
저자명
유정연,정선경,최미희,한상범,이경률,이희주,Yoo. Jeong-Yeon,Joung. Sun-Koung,Choi. Mee-Hee,Han. Sang-Beom,Lee. Kyung-Ryul,Lee. Hee-Joo
간행물명
藥劑學會誌
권/호정보
2003년|33권 3호|pp.215-221 (7 pages)
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한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

A bioequivalence study of $Ambrect^{TM}$ tablets (Dong Wha Pharm. Ind. Co., Ltd.) to $Mucopect^{TM}$ tablets (Boehringer Ingelheim Korea, Ltd.) was conducted according to the guideline of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korea volunteers received each medicine at the ambroxol hydrochloride dose of 30 mg in a $2{ imes}2$ 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. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calulated 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 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 $Ambrect^{TM}/Mucopect^{TM}$ 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 demonstrated the bioequivalence of $Ambrect^{TM};and;Mucopect^{TM}$ with respect to the rate and extent of absorption.