Comparative oral bioavailability of azimilide dihydrochloride in the fed and fasted states

Aims This study investigated the relative oral bioavailability of azimilide dihydrochloride following administration in the fed (high-fat meal) and fa sted states. Methods This was a single-dose, randomized, two-way crossover study in 30 h ealthy, Caucasian, male subjects. Following oral administration, blood samp les were collected over 27 days and analysed for azimilide using h.p.l.c. w ith u.v. detection. Pharmacokinetic parameters were determined using 'nonco mpartmental' analysis and compared using an ANOVA and 90% or 95% confidence intervals. Results The extent of absorption was equivalent in the fed and fasted state s (ratio = 96.2%; 90% CI = 90.5% -102.4%). However, C-max was decreased 19% following a high-fat meal (ratio = 81.4%; 90% CI = 76.2% -87.0%). No diffe rence in t(max) or t(1/2,z) was observed. Conclusions Azimilide dihydrochloride may be orally administered to patient s without regard to the prandial state.