Oral Bioavailability of Atenolol

Abstract

The bioavailability of two formulations of atenolol was compared in an open, randomized crossover study. Each film-coated tablet contained 100 mg of active drug. The plasma concentrations of atenolol were determined using a newly developed and specific high-performance liquid chromatography procedure. The areas under the concentration – time curves (AUC) were calculated, as were pair differences and ratios for individual AUC values and for maximum plasma levels. The latter were determined (C_max.(c)) and calculated (C_max.(c)) at the corresponding time values (t _max.) for test and reference formulations, and were then tested for statistical significance. The 95% confidence limits for both test and reference preparations, taken according to Westlake or Wilcoxon, were found to be 80.0 − 114.7% for AUC, 80.2 − 119.9% for C _max. and 74.5 − 132.8% for t _max. In terms of pharmacokinetic target criteria, therefore, it can be seen that there were no substantial differences between the two film-coated tablets. The two atenolol preparations, therefore, may be classified as bioequivalent.