Study on the bioequivalence of Atenolol tablets

Objective: To study difference in pharmacokinetices and relative bioavailability of atenolol produced by difference factories.Methods: A single oral dose of 50mg atenolol tablets was given respectively to22 healthy voluntees in an open randomized crossover test. Atenolol concentration was determined by SPE-HPLC.Pharmacokinetic parametres were calculated by non-compartment model. Bioequivalence analysis was done to C_(max)、T_(max )and AUC_(0→24). Results: The main pharmacokinetics of the two products(test and reference) were as follow.T_(max) were(2.61±0.75)h and(2.52±(0.65))h,(P0.05);C_(max )were(322.9±107.4)ng/mL and(325±126.1)ng/mL(P0.10);t_(1/2β) were(5.69±1.11)h and(5.36±1.16)h;AUC_(0→24) were(2587.4±808.0)ng/mL·h and(2571.3±810.4)ng/mL·h;AUC_(0→∞)were(2739.8±(809.7))ng/mL·h and(2704.7±823.2)ng/mL·h. Conclusion: The two products were bioequivalent,the relative bioavailability was(100.6±33.0)%.