THE INFLUENCE OF FOOD ON THE DISPOSITION OF THE ANTIEPILEPTIC RUFINAMIDE IN HEALTHY-VOLUNTEERS

The effect of food on the pharmacokinetics of the antiepileptic rufina mide was investigated in healthy volunteers. Twelve subjects were trea ted with single per-oral doses of 600 mg of rufinamide after overnight fasting or a fat and protein rich breakfast. Mean (+/-S.D.) areas und er the plasma concentration-time curves (AUCs) of the unchanged compou nd were 57.2 (16) mu g mL(-1) h when given to the fasted volunteers an d 81.7 (22.2) mu g mL(-1) h (p = 0.0001) when given after the breakfas t. The average AUC was increased by 44% when rufinamide was given with food and the maximum concentration (C-max) by about 100%. The time at which C-max was reached (t(max)) was shorter (8 h in fasted condition s and 6 h in fed after breakfast); the terminal half-life was not infl uenced by concomitant intake of food. (C) 1998 John Wiley & Sons, Ltd.