Bioequivalence of domestic and imported bicalutamide tablets in healthy volunteers

Objective To study the pharmacokinetic characteristics of bicalutamide in healthy volunteers and to compare the bioavailability and bioeqeivalence of domestic tablets with imported tablets. Methods A single oral dose of 50 mg either domestic tablets (test group) or imported tablets (reference group) was given to 44 healthy volunteers in a randomized parallel design. The concentrations of bicalutamide in plasma were determined by HPLC. Pharmacokinetic parameters were calculated from the plasma concentration - time data with the DAS software and the bioequivalence of the two formulations were evaluated by the analysis of variance and the two one-sided t-test.Results The pharmacokinetic parameters of the test and the reference tablets for bicalutamide were as follows: tmax were (21 ± 12)and(23 ± 12)h,Cmax were (538 ± 151)and (619 ± 167) ng·mL-1,AUC0-n were (94.4 ± 20.6) and (102.3 ± 17.4)μg·h·mL-1 ,AUC0-∞ were(102.1 ± 20.8) and (108.7 ± 18.9) μg·h·mL-1, respectively. Relative bioavailability of domestic tablets was 93.9%.Conclusion Two formulations are bioequivalence.