Relative bioavailabillty and bioequivalence of atenolol tablets in healthy volunteers

Objective To evaluate the relative bioavailability and bioequivalence of imported atenolol tablets and those produced by Christo Pharmaceuticals Ltd.of Hong Kong.Methods A single oral dose of 100 mg test preparation A,B,and reference preparation R was given to 18 healthy male Chinese volunteers according to 3×3 crossover design.The concentrations of atenolol in the plasma at different time were determined by high-performance liquid chromatography with fluorescence detection.The main pharmacokinetic parameters were analyzed by DAS statistics software.The main pharmacokinetic parameters of A,B and R were as follows:Cmax was(376.7±122.3),(389.9±115.5),and(398.0±118.0) ng·mL-1;tmax was(2.8±0.8),(2.8±1.0),and(2.7±0.7) h;AUC0→24 was(3 193.3±993.5),(3 069.0±915.7),and(3 218.6±994.9) ng·h·mL-1;AUC0→∞ was(3 530.9±1 119.2),(3 333.1±1 047.7),and(3 545.5±1 260.3)ng·h·mL-1.Results The relative bioavailability of A and B was(101±19)% and(97±14)%.Conclusion The 2 atenolol test preparations are bioequivalent with the reference preparation.