테놀민 정(아테놀올 50 mg)에 대한 신일아테놀올 정의 생물학적 동등성

Abstract

This study was conducted to compare the bioavailability of a generic product of Sinil Atenolol Tablets (Sinil Pharmaceutical Co., Ltd., Korea) with the innovator product, Tablets in 20 healthy Korean volunteers. The volunteers received a single 50 mg dose of each atenolol formulation according to a randomized, two-way crossover design. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs time curves, the following parameters were compared: area under the plasma concentration-time curve (AUC), peak plasma concentration , time to reach peak plasma concentration , and terminal first order elimination half-life . No statistically significant difference was obtained between the values, and the logarithmic transformed AUC and values of the two products. The 90% confidence for the ratio of the logarithmically transformed AUC and values of Sinil Atenolol Tablets over those of Tablets were calculated to be between 0.99 and 1.07, and 1.04 and 1.16, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of in Tablet group was 3.68 hour, and that in Sinil Atenolol Tablet group was 3.65 hour. The values of between the two products were found comparable, and the mean values of Tablets and Sinil Atenolol Tablets were 5.9 and 6.0 hour, respectively. Based on these results, it was concluded that Sinil Atenolol Tablets were comparable to Tablets in both the rate and extent of absorption, indicating that Sinil Atenolol Tablets were bioequivalent to the reference product, Tablets