The effect of food on the relative bioavailability of fadrozole hydrochloride

The effect of food on the pharmacokinetic disposition of fadrozole hydrochloride was evaluated in nine healthy male and female volunteers. Single 12 mg doses of fadrozole were orally administered to subjects immediately following a standardized meal or after fasting for 12 h, in a randomized crossover design. No statistically significant treatment differences were detected for the pharmacokinetic parameters AUC and half-life. Cmax was significantly reduced by 15% for the fed treatment relative to the fasted treatment, and tmax was delayed by 39%. These findings indicate that the concomitant ingestion of food with fadrozole delays the gastric emptying and/or absorption of fadrozole, but has no effect on the extent of absorption.