THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF FADROZOLE HYDROCHLORIDE

The effect of food on the pharmacokinetic disposition of fadrozole hyd rochloride was evaluated in nine healthy male and female volunteers. S ingle 12 mg doses of fadrozole were orally administered to subjects im mediately 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. C(max) was significantly reduced by 15% for the fed treatme nt relative to the fasted treatment, and t(max) was delayed by 39%. Th ese findings indicate that the concomitant ingestion of food with fadr ozole delays the gastric emptying and/or absorption of fadrozole, but has no effect on the extent of absorption.