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)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Depression - Major Depressive Disorder

Treatments: Drug: desvenlafaxine succinate sustained release

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190514

B2061035

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Bioequivalence and Food effect

Experimental group

Treatment:

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release

Drug: desvenlafaxine succinate sustained release