Bioequivalence Study of atenolol:Pharmacokinetic and Pharmacodynamic Evaluation

Abstract

This study was designed to assess pharmacokinetic parameters and pattern of pharmacodynamic effects (heart rate and blood pressure) of 100 mg Atenolol tablets in comparison with those of 100 mg Tenormin tablets as reference. A double blind cross over study was carried out among 12 healthy male subjects. A HPLC system using RP-C18 column and fluorescence detector was used to assess atenolol in plasma. Heart rate and blood pressure were measured by the trained clinic staff. Peak levels were observed about 2.97h for Atenolol and 3.73h for Tenormin after oral dosing. Cmax values for both formulations were about 0.49 mg/ml. AUC0-24 was about 4.89 mg.h/ml for the test and 5.31 mg.h/ml for the reference group. Atenolol given orally caused a significant reduction in heart rate, systolic and diastolic blood pressure after administration of two formulations (P<0.05). It is concluded that two formulations are not significantly different in terms of pharmacodynamic and pharmacokinetic parameters which were studied.