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 male volunteers. Sixteen healthy young male volunteers participated in this single-center, open-label, single-dose, crossover study. Each volunteer received a single 300-mg irbesartan tablet under fasted conditions and 5 minutes after a high-fat breakfast, with administrations separated by a 7-day washout period. Serial blood samples were collected over 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 concentration (Cmax) and area under the concentration-time curve (AUC) of irbesartan. The presence of food was associated with a slightly prolonged time to maximum concentration (tmax) and half-life (t1/2), but the differences were not statistically significant. The results of this study indicate that food does not affect the bioavailability of irbesartan. Thus, irbesartan can be administered without regard to meals.
Vachharajani
N N
NN
Department of Metabolism, Bristol-Myers Squibb, Princeton, NJ 08543-4000, USA.
Shyu
W C
WC
Mantha
S
S
Park
J S
JS
Greene
D S
DS
Barbhaiya
R H
RH
D000284:Administration, Oral; D000328:Adult; D000959:Antihypertensive Agents / Q000097:blood / Q000493:pharmacokinetics*; D001682:Biological Availability; D001713:Biphenyl Compounds / Q000097:blood / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004041:Dietary Fats / Q000008:administration & dosage*; D018565:Food-Drug Interactions; D006801:Humans; D000077405:Irbesartan; D008297:Male; D013777:Tetrazoles / Q000097:blood / Q000493:pharmacokinetics*
D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D004041:Dietary Fats; D013777:Tetrazoles; D000077405:Irbesartan