Comparative bioavailability study of two atenolol tablet preparations

A study was conducted to compare the bioavailability of a generic product o f atenolol (Normaten FC) with the innovator product, Tenormin. Twelve healt hy adult volunteers participated in the study conducted according to a rand omized two-way crossover design. The preparations were compared using area under the plasma concentration-time curve AUC(0-infinity), peak plasma conc entration C-max and time to reach peak plasma concentration T-max. No stati stically significant difference was obtained between the T-max values and t he logarithmic transformed AUC(0-infinity) and C-max values of the two prod ucts. Moreover, the 90% confidence interval for the ratio of the logarithmi cally transformed AUC(0-infinity) values of Normaten FC over those of Tenor min was found to lie between 0.82 and 0.98 while that of the logarithmicall y 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 significant ly different statistically. The tin values obtained in our study were sligh tly longer than those reported in the literature for other population group s.