테놀민 정(아테놀올 50㎎)에 대한 신일아테놀올 정의 생물학적 동등성 = Bioequivalence of Sinil Atenolol Tablets to Tenormin Tablets (Atenolol 50㎎)

다국어 초록 (Multilingual 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, Tenormin^?? Tablets in 20 healthy Korean volunteers. The volunteers received a single 50㎎ 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 (C_max), time to reach peak plasma concentration (T_max), and terminal first order elimination half-life (t_1/2). No statistically significant difference was obtained between the T_max values, and the logarithmic transformed AUC and C_max values of the two products. The 90% confidence for the ratio of the logarithmically transformed AUC and C_max values of Sinil Atenolol Tablets over those of Tenormin^?? 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 T_max in Tenormin^?? Tablet group was 3.68 hour, and that in Sinil Atenolol Tablet group was 3.65 hour. The values of t_1/2 between the two products were found comparable, and the mean t_1/2 values of Tenormin^?? 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 Tenormin^?? Tablets in both the rate and extent of absorption, indicating that Sinil Atenolon Tablets were bioequivalent to the reference product, Tenormin^?? Tablets.