The Effects of Food on the Bioavailability of Fenofibrate Administered Orally in Healthy Volunteers via Sustained-Release Capsule
Authors: Yun, Hwi-Yeol1; Eun Joo Lee,1; Soo Youn Chung,2; Choi, Sun-Ok2; Hyung Kee Kim,3; Kwon, Jun-Tack3; Kang, Wonku4; Kwon, Kwang-Il1
Source: Clinical Pharmacokinetics, Volume 45, Number 4, 2006 , pp. 425-432(8)
Publisher: Adis International
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Abstract:
Objective: To examine the effects of food on plasma concentration and bioavailability of fenofibrate administered as a sustained-release capsule.Methods: Twenty-four healthy Korean volunteers were enrolled in a randomised, open-label, balanced, three-treatment, three-period, three-sequence, single oral dose, crossover pharmacokinetic study. A single dose of fenofibrate (250mg sustained-release capsule) was administered on three occasions - after overnight fasting, after consumption of a standard breakfast and after a high-fat breakfast. Serial blood samples were collected for the next 72 hours. Plasma fenofibric acid concentrations were measured by high-performance liquid chromatography, and pharmacokinetic parameters were calculated.Results: The pharmacokinetic parameters were significantly affected by food intake. The high-fat breakfast affected the rate of absorption of fenofibrate more than the standard breakfast and fasted conditions. Specifically, the area under the plasma concentration-time curve from time zero to infinity (AUC∞) and peak plasma concentration (Cmax) increased 2.45-fold and 2.89-fold, respectively, between the fasted and standard-fed conditions (p < 0.01). In addition, the high-fat meal caused 3.34-fold and 3.82-fold increases compared with the fasted condition in AUC∞ and Cmax, respectively. A one-compartment open model with lag time successfully described the plasma concentrations of fenofibric acid.Conclusion: In healthy volunteers, AUC∞ and Cmax of fenofibrate, when administered via sustained-release capsules immediately after the consumption of food, was increased significantly from the fasting conditions (p < 0.01). The greatest AUC∞ and Cmax occurred when the capsules were taken after a high-fat breakfast.Document Type: Research article
Affiliations: 1: 1 College of Pharmacy, Chungnam National University, Daejeon, Korea 2: 2 National Institute of Toxicological Research, Seoul, Korea 3: 3 College of Medicine, Soonchunhyang University, Chunan, Korea 4: 4 College of Pharmacy, Catholic University of Daegu, Kyungbuk, Korea
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