NCT01190514

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 1, Open-Label, Randomized, Single-Dose, 4-Treatment, 4-Period Crossover Bioequivalence Study Comparing 25 Mg and 50 Mg Formulations of DVS-233 SR and Investigate Food Effect on 50 Mg Formulations of DVS-233 SR Tablet Under Fed and Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depression - Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	desvenlafaxine succinate sustained release	Two tablets of 25 mg, single administration, under fed condition
DRUG	desvenlafaxine succinate sustained release	One tablet of 50 mg, single administration, under fed condition
DRUG	desvenlafaxine succinate sustained release	Two tablets of 25 mg, single administration, under fast condition
DRUG	desvenlafaxine succinate sustained release	One tablet of 50 mg, single administration, under fast condition

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-08-27
• Last updated: 2012-01-27
• Results posted: 2012-01-27

Locations

1 site across 1 country: Belgium