The influence of food on the disposition of the antiepileptic rufinamide in healthy volunteers.

The effect of food on the pharmacokinetics of the antiepileptic rufinamide was investigated in healthy volunteers. Twelve subjects were treated with single pre-oral doses of 600 mg of rufinamide after overnight fasting or a fat and protein rich breakfast. Mean (+/- S.D.) areas under the plasma concentration-time curves (AUCs) of the unchanged compound were 57.2 (16) micrograms mL-1 h when given to the fasted volunteers and 81.7 (22.2) micrograms mL-1 h (p = 0.0001) when given after the breakfast. The average AUC was increased by 44% when rufinamide was given with food and the maximum concentration (Cmax) by about 100%. The time at which Cmax was reached (tmax) was shorter (8 h in fasted conditions and 6 h in fed after breakfast); the terminal half-life was not influenced by concomitant intake of food.

RCT Entities:   Population Interventions Outcomes