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


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Abstract

AimsThis study investigated the relative oral bioavailability of azimilide dihydrochloride following administration in the fed (high-fat meal) and fasted states.MethodsThis was a single-dose, randomized, two-way crossover study in 30 healthy, Caucasian, male subjects. Following oral administration, blood samples were collected over 27 days and analysed for azimilide using h.p.l.c. with u.v. detection. Pharmacokinetic parameters were determined using 'noncompartmental' analysis and compared using an ANOVA and 90% or 95% confidence intervals.ResultsThe extent of absorption was equivalent in the fed and fasted states (ratio = 96.2%; 90% CI = 90.5% - 102.4%). However, Cmax was decreased 19% following a high-fat meal (ratio = 81.4%; 90% CI = 76.2% - 87.0%). No difference in tmax or t1/2,z was observed.ConclusionsAzimilide dihydrochloride may be orally administered to patients without regard to the prandial state.

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