LACK OF EFFECT OF FOOD ON THE ORAL BIOAVAILABILITY OF IRBESARTAN IN HEALTHY MALE-VOLUNTEERS

This study was conducted to evaluate the effects of a high-fat meal on the oral bioavailability of an 300-mg irbesartan tablet in healthy ma le volunteers. Sixteen healthy young male volunteers participated in t his single-center, open-label, single-dose, crossover study. Each volu nteer received a single 300-mg irbesartan tablet under fasted conditio ns and 5 minutes after a high-fat breakfast, with administrations sepa rated by a 7-day washout period. Serial blood samples were collected o ver a 72-hour period, and plasma samples were analyzed for irbesartan using a validated high-performance liquid chromatography/fluorescence procedure. Food had no statistically significant effects on the peak c oncentration (C-max) and area under the concentration-time curve (AUC) of irbesartan. The presence of food was associated with a slightly pr olonged time to maximum concentration (t(max)) and half-life (t(1/2)), but the differences were not statistically significant. The results o f this study indicate that food does not affect the bioavailability of irbesartan. Thus, irbesartan can be administered without regard to me als. (C) 1998 The American College of Clinical Pharmacology.