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- Title
PI-68.
- Authors
Richards, L. S.; Plotka, A.; Behrle, J. A.; Posener, J. A.; Nichols, A. I.
- Abstract
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 Tmax 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 t½ values for desvenlafaxine were not altered by administration with food. With the exception of Cmax under high fat conditions, both Cmax and AUC∞ for desvenlafaxine met bioequivalence test criteria (90% confidence interval[CI] within 80% to 125%); the 90% CI for Cmax 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
- Subjects
DRUG efficacy; FAT content of food; FAT; PHARMACOLOGY; CLINICAL medicine research
- Publication
Clinical Pharmacology & Therapeutics, 2006, Vol 79, Issue 2, pP25
- ISSN
0009-9236
- Publication type
Case Study
- DOI
10.1016/j.clpt.2005.12.089