아리셉트 정(염산도네페질 10 mg)에 대한 돈페질 정의 생물학적동등성

Abstract

The purpose of the present study was to evaluate the bioequivalence of two donepezil tablets, tablet (Dae Woong Pharm. Co., Ltd., Korea, reference drug) and 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 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. , (the area under the plasma concentration-time curve from time zero to 240 hr) was calculated by the linear trapezoidal rule method. (maximum plasma drug concentration) and (time to reach )were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed and , 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 and were log 0.95log 1.03 and log 0.94log 1.08, respectively. These values were within the acceptable bioequivalence intervals of log 0.80log 1.25. Taken together, our study demonstrated the bioequivalence of and with respect to the rate and extent of absorption.