THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF MULTIPLE‐DOSE TERBINAFINE IN YOUNG AND ELDERLY HEALTHY SUBJECTS

Pharmacokinetic (PK) parameters for terbinafine were assessed in 15 elderly and 15 young healthy subjects randomized to receive 250 mg Lamisil™ once daily for 15 d in a two‐period, two‐treatment, two‐sequence, crossover (fed versus fasted) design within age groups. On each treatment day except days 8 and 15, subjects took Lamisil™ with food at 8:00 a.m. On days 8 and 15, subjects took the drug under either fed or fasting conditions according to treatment sequence, and 24 h PK profiles were obtained. Two analyses of the pharmacokinetic data were undertaken. In a noncompartmental analysis, AUC0–24 h , Cmax , C0 h , and tmax were computed for each subject on each of days 8 and 15, and the influences of food condition and age on these variables were assessed by analysis of variance. AUC0–24 h and C0 h were found to be larger (p