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From the Department of Clinical Pharmacokinetics and Pharmacodynamics (Drs. Cook and Randinitis), Pfizer Global Research and Development, Ann Arbor, MI; and Department of Neurology and Neuroscience (Dr. Wilder), College of Medicine, University of Florida, Gainesville.
Address correspondence and reprint requests to Dr. J. Cook, Department of Clinical Pharmacokinetics and Pharmacodynamics, Pfizer Global Research and Development, 2800 Plymouth Road, Ann Arbor, MI 48105; e-mail: Jack.Cook{at}Pfizer.com
The authors examined the effect of food on the bioavailability of Dilantin Kapseals in a nonblinded, single 100-mg dose, randomized, crossover trial. Drug was administered after an 8-hour fast and after a high-fat meal. Differences in mean dietary state values were +6% for maximum concentrations (Cmax) and -2% for area under the curve. Associated 90% CI were within US Food and Drug Administration criteria, confirming the absence of a food effect. Thus, patients may take 100-mg Dilantin Kapseals without regard to meals.
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