Absence of a food effect with a 145 mg nanoparticle fenofibrate tablet formulation.
Author(s): Sauron R, Wilkins M, Jessent V, Dubois A, Maillot C, Weil A
Affiliation(s): Department of Clinical Pharmacokinetics, Laboratoires Fournier S.A., 50, Rue de Dijon, 21121 Daix, France. email@example.com
Publication date & source: 2006-02, Int J Clin Pharmacol Ther., 44(2):64-70.
Publication type: Randomized Controlled Trial
OBJECTIVES: The present study was conducted to assess the effect of food on the bioavailability of fenofibric acid from a new tablet formulation containing fenofibrate nanoparticles. METHODS: In this 3-way crossover study, 45 subjects received in a random order one 145 mg fenofibrate tablet under high-fat fed (HFF), low-fat fed (LFF) or fasting (reference) conditions. Plasma concentrations of fenofibric acid were determined up to 120 hours post-dose. Comparisons were made between test (HFF and LFF) and reference conditions (fasting). RESULTS: Very close values of pharmacokinetic parameters were obtained following the three diffiferent regimens. The 90% confidence intervals (CI) for the ratio of geometric means of HIFF versus fasting condition were (1.018-1.088) for AUCinfinity, (1.020-1.090) for AUCt and (0.963-1.054) for Cmax with point estimate:s of 1.052, 1.054 and 1.007, respectively. The 90% CI for the geometric means of LFF versus fasting condition were (0.978-1.046) for AUGinfinity, (0.981-1.047) for AUCt and (0.964-1.055) for Cmax with point estimates of 1.012, 1.013 and 1.009, respectively. They all fall within the required limits for bioequivalence (0.80-1.25). A slightly prolonged tmax was observed following HFF conditions (4.3 +/- 1.9 hours, versus 3.6 +/- 1.2 hours and 2.3 +/- 0.7 hours under LFF and fasting conditions, respectively), without any effect on mean Cmax. CONCLUSION: The peak and overall exposures from the new 145 mg fenofibrate tablet were not affected by food. Therefore, this new fenofibrate tablet may be taken without regard to the timing of meals.