포사맥스 정(알렌드론산나트륨 70 mg)에 대한 대웅 알렌드로네이트 정 70 mg의 생물학적동등성

Abstract

A bioequivalence of Daewoong (Daewoong Pharmaceutical Co., Ltd., Korea) and tablets (MSD Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). A single 70 mg dose of sodium alendronate of each medicine was administered orally to 56 healthy male volunteers. This study was performed in a crossover design. Concentrations of alendronate in the urine were monitored by a high-performance liquid chromatography (HPLC). (cumulative urinary excreted amount from time 0 to last sampling interval) was calculated by the accumulation of the urinary excreted alendronate. (maximum urinary excretion rate) and (time to reach ) were compiled from the urinary excretion rate - time data. Analysis of variance was performed using logarithmically transformed and . No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the and for Daewoong were 0.89-1.12 and 0.82-1.02, respectively. This study demonstrated the bioequivalence of Daewoong and with respect to the rate and extent of absorption.