- 아리셉트 정(염산도네페질 10 mg)에 대한 돈페질 정의 생물학적동등성
- ㆍ 저자명
- 이현수,서지형,강일모,이헌우,류주희,이경태,Lee. Hyun-Su,Seo. Ji-Hyung,Kang. Il-Mo,Lee. Heon-Woo,Ryu. Ju-Hee,Lee. Kyung-Tae
- ㆍ 간행물명
- 藥劑學會誌
- ㆍ 권/호정보
- 2007년|37권 1호|pp.57-62 (6 pages)
- ㆍ 발행정보
- 한국약제학회
- ㆍ 파일정보
- 정기간행물| PDF텍스트
- ㆍ 주제분야
- 기타
The purpose of the present study was to evaluate the bioequivalence of two donepezil tablets, $Aricept^{TM}$ tablet (Dae Woong Pharm. Co., Ltd., Korea, reference drug) and $Donpezil^{TM}$ tablet (Dong Wha Pharm. Ind. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received one tablet containing donepezil hydorchloride 10 mg in a $2{ imes}2$ crossover study. There was a three-week washout period between the doses. Plasma concentrations of donepezil were monitored by an LC-MS/MS far over a period of 240 hr after the administration. $AUC_t$, (the area under the plasma concentration-time curve from time zero to 240 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 carried out using logarithmically transformed $AUC_t$ and $C_{max}$, No significant sequence effects were found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ and $C_{max}$ were log 0.95${sim}$log 1.03 and log 0.94${sim}$log 1.08, respectively. These values were within the acceptable bioequivalence intervals of log 0.80${sim}$log 1.25. Taken together, our study demonstrated the bioequivalence of $Aricept^{TM}$ and $Donpezil^{TM}$ with respect to the rate and extent of absorption.