Article date: March 2000
By: Alfred E. Corey, Jeffrey R. Agnew, Suzanne N. Valentine, John D. Nesbitt, Dan L. Wagner, James H. Powell, Gary A. Thompson, in Volume 49, Issue 3, pages 279-282
Aims This study investigated the relative oral bioavailability of azimilide dihydrochloride following administration in the fed (high‐fat meal) and fasted states.
Methods This 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.
Results The 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 t½,z was observed.
Conclusions Azimilide dihydrochloride may be orally administered to patients without regard to the prandial state.
DOI: 10.1046/j.1365-2125.2000.00139.x
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