Comparative Bioavailability Study of Two Atenolol Tablet Preparations

Abstract

A study was conducted to compare the bioavailability of a generic product of atenolol (Normaten FC) with the innovator product, Tenormin. Twelve healthy adult volunteers participated in the study conducted according to a randomized, two-way crossover design. The preparations were compared using area under the plasma concentration–time curve AUC_0–∞, peak plasma concentration C_max, and time to reach peak plasma concentration T_max. No statistically significant difference was obtained between the T_max values and the logarithmic transformed AUC_0–∞ and C_max values of the two products. Moreover, the 90% confidence interval for the ratio of the logarithmically transformed AUC_0–∞ values of Normaten FC over those of Tenormin was found to lie between 0.82 and 0.98, while that of the logarithmically transformed C_max values was between 0.82 and 1.09, both being within the bioequivalence limit of 0.80–1.25. The values of elimination half-life t_1/2 between the two products were also found comparable and not significantly different statistically. The t_1/2 values obtained in our study were slightly longer than those reported in the literature for other population groups.