BIOAVAILABILITY OF TWO FORMULATIONS OF BICALUTAMIDE 50 mg
Background: The purpose of this study was to evaluate the bioequivalence of a generic formulation of bicalutamide 50 mg tablets (test°) vs. the available branded formulation (reference*).
Methods and findings: A single-dose, randomized-sequence, open label, 2-period crossover study was conducted in 30 healthy male volunteers. A single oral dose of 50 mg of the test or reference formulation was followed by a 45 day washout period after which subjects received the alternative formulation. Blood samples were collected before dosing (Time 0) and at 5.0, 7.0, 9.0, 11.0, 14.0, 18.0, 20.0, 30.0, 48.0, 72.0, 120.0, 168.0, 336.0, 504.0, and 672.0 h after dosing. A very close follow-up helped subjects not to miss the second phase. Plasma samples were assayed for bicalutamide using a selective and sensitive HPLC method with a UV detector at a wave length of 272 nm. The Cmax, tmax, AUC0-t(672 h), AUC0-∞, and t1/2 were determined from the plasma concentration-time profiles of both formulations.
Conclusions: The formulations were considered bioequivalent since 90% confidence intervals of the geometric mean ratios for Cmax, AUC0-t, and AUC0-∞ were within the regulatory range of 80-125%.