Steady-state hydroxyflutamide plasma levels after the administration of two dosage forms of flutamide.

A bioavailability study of randomized cross-over design was carried out in eight volunteers who were given a 48-h flutamide treatment consisting of 250-mg tablets three times daily or 400-mg sustained-release tablets twice daily, followed 3 weeks later by the alternative dosage form. Just before the last dose and 15 times during the subsequent 24 h, blood samples were obtained for the determination of plasma hydroxyflutamide (the active metabolite of flutamide) levels by high-performance liquid chromatography. No statistically significant differences between the two dosage forms were found for the lag time, rate of initial increase in concentration, peak plasma concentration, mean hydroxyflutamide concentration within one dosing interval or 24-h AUC value. One subject presented mild and transient nausea during both treatment periods. After the first treatment period (250-mg tablets), an increase in serum bilirubin was observed in another volunteer, who was withdrawn from the study. It may be concluded that both dosage forms were bioequivalent.

RCT Entities:   Population Interventions Outcomes