Conditions: Depression - Major Depressive Disorder
Keywords: DVS SR healthy Bioequivalence study
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 41
Healthy volunteers: yes

Brief summary:
To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.

To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg SR formulation of DVS.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: desvenlafaxine succinate sustained release intervention 2: desvenlafaxine succinate sustained release intervention 3: desvenlafaxine succinate sustained release intervention 4: desvenlafaxine succinate sustained release
Intervention descriptions: intervention 1: Two tablets of 25 mg, single administration, under fed condition intervention 2: One tablet of 50 mg, single administration, under fed condition intervention 3: Two tablets of 25 mg, single administration, under fast condition intervention 4: One tablet of 50 mg, single administration, under fast condition

Protocol document: