Bioequivalence of bicalutamide tablet in healthy volunteers

Objective To study the pharmacokinetic characteristics and bioequivalence of bicalutamide tablets in healthy volunteers.Methods A single oral dose of 50 mg bicalutamide test(domestic)or control(import)tablets was given to 20 healthy volunteers in an open randomized cross-over study.The concentrations of bicalutamide were determined with HPLC.The pharmacokinetic parameters were calculated with 3P97 and the bioequivalent test was performed with SAS.Results The main pharmacokinetic parameters of the test and control drug were as follows:Cmax,691.50 vs 697.30 μg/L;Tmax,20.65 vs 24.10 h;AUC0～∞,148 124 vs 153 782 μg·h/L;t1/2,127.46 vs 131.06 h,respectively.The relative bioavailability was 99.43%.Conclusion The test bicalutamide tablet is bioequivalent to the control formulation.