Effect of food on the bioavailability of 100-mg dilantin Kapseals.
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 (C(max)) 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.
Cook
J
J
Department of Clinical Pharmacokinetics and Pharmacodynamics, Pfizer Global Research and Development, Ann Arbor, MI 48105, USA. Jack.Cook@Pfizer.com
Randinitis
E
E
Wilder
B J
BJ
D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D002214:Capsules; D016001:Confidence Intervals; D018592:Cross-Over Studies; D004041:Dietary Fats / Q000493:pharmacokinetics*; D005215:Fasting / Q000378:metabolism; D005260:Female; D005502:Food; D006801:Humans; D008297:Male; D008875:Middle Aged; D010672:Phenytoin / Q000097:blood / Q000493:pharmacokinetics*
D000927:Anticonvulsants; D002214:Capsules; D004041:Dietary Fats; D010672:Phenytoin