PI‐68

BACKGROUND/AIMS To assess the effects of a low‐, medium‐, or high‐fat meal on the relative bioavailability and pharmacokinetics (PK) of desvenlafaxine following administration of desvenlafaxine succinate extended release (DVS). METHODS This was a single‐dose, open‐label, randomized, 4‐period, 4‐sequence, crossover, inpatient study. A single oral 200‐mg dose of DVS was administered to 33 healthy male and female subjects after an overnight fast (>10 hours), or after the completion of a low‐, medium‐, or high‐fat breakfast on study day 1 of each period. Blood samples were obtained over 72 hours. A model‐independent method of PK analysis was used to analyze plasma concentrations of desvenlafaxine. The PK parameters of desvenlafaxine were compared by dosing condition using an analysis of variance for a 4‐period crossover study. RESULTS The median T max for desvenlafaxine was approximately 6 hours after administration of DVS under fasting conditions and was delayed by about 2 hours when administered with food. Cl/F and t ½ values for desvenlafaxine were not altered by administration with food. With the exception of C max under high fat conditions, both C max and AUC ∞ for desvenlafaxine met bioequivalence test criteria (90% confidence interval[CI] within 80% to 125%); the 90% CI for C max under high‐fat conditions was 108% to 125.05%. CONCLUSION These results suggest that PK should not be a factor in considering whether to administer DVS with or without food. Clinical Pharmacology & Therapeutics (2005) 79 , P25–P25; doi: 10.1016/j.clpt.2005.12.089