Effect of food on high-dose oral ganciclovir disposition in HIV-positive subjects

Journal of Clinical Pharmacology
D JungA Dorr

Abstract

The effect of food on the steady-state pharmacokinetics of ganciclovir following high-dose oral ganciclovir in HIV- and CMV-seropositive subjects was investigated in an open-label, randomized, two-treatment crossover study. Over 2 consecutive weeks, subjects received in random order multiple oral doses of ganciclovir 2,000 mg tid for 3 consecutive days either on an "empty stomach " (i.e., at least 1 hour before or 2 hours after a meal or snack) or within 30 minutes of finishing a meal. For the 3 days of dosing each week, the breakfast consisted of a standardized 602 calorie, high-fat (46.5%) meal, while the contents of lunch, dinner, and snacks met American Dietetic Association recommendations (25%-35% fat). Serial blood samples over 24 hours were obtained on day 3 of each regimen over the first dosing interval. When ganciclovir was administered within 30 minutes following the breakfast, there was a mean increase of 110.6% +/- 79.0% and 114.1% +/- 81.7% in Cmax0-5 and AUC0-5, respectively, with a prolongation of mean Tmax from 1.8 to 2.7 hours. Over the total day of dosing, there was a mean increase of 47.6% +/- 12.3% and 97.2% +/- 30.9% in Cmax0-24 and AUC0-24, respectively, and a 36.0% +/- 18.0% decrease in half-life when dos...Continue Reading

Citations

Aug 6, 1999·Journal of Clinical Pharmacology·D Jung, A Dorr
Sep 8, 2010·Journal of Pharmaceutical Sciences·James M Butler, Jennifer B Dressman

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