Assessment of pharmacokinetics and bioequivalence of bicalutamide tablets in healthy volunteers

Objective To study the pharmacokinetics and bioequivalence of bicalutamide tablets.Methods An HPLC method was developed to determine the plasma concentrations of bicalutamide in 40 healthy male volunteers following an oral 50 mg bicalutamide tablets in a one period parallel design test.Bicalutamide's plasma concentration-time curves were ploted and the main pharmacokinetic parameters were calculated.Results The main pharmacokinetic parameters of test and reference formulation were:Tmax=(19.3±12.4)and(24.6±10.7)h,Cmax=(1 137.2±202.3)and(1 094.2±199.0)ng/mL,t1/2=(98.2±22.0)and(106.0±19.4)h,AUC0-t=(178 535.6±36 640.9)and(186 744.4±44 359.9)ng/(h·mL),AUC0-∞=(185 230.9±38 327.7)and(193 807.6±46 347.8)ng/(h·mL),respectively.The value of relative bioavailability was 95.6%.Conclusion According to the two-one-sided t-tests,the two formulations are bioequivalent.