Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)

Phase 1CompletedNCT01190514

Pfizer41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression - Major Depressive Disorder

Interventions

desvenlafaxine succinate sustained releaseDRUG

Two tablets of 25 mg, single administration, under fed condition

desvenlafaxine succinate sustained releaseDRUG

One tablet of 50 mg, single administration, under fed condition

desvenlafaxine succinate sustained releaseDRUG

Two tablets of 25 mg, single administration, under fast condition

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female subjects. Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)

Area under the plasma concentration versus time curve from time zero (pre-dose) to 48 hours post dose; measured as nanograms multiplied by hours divided by milliliters (ng\*hr/mL).