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

Completed

• Conditions: Depression - Major Depressive Disorder
• Interventions: Drug: desvenlafaxine succinate sustained release

• Registration Number: NCT01190514
• Lead Sponsor: Pfizer

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

Not available

Study Timeline

• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Study Start: 2010-09
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-12
• Results First Submitted: 2011-12-21
• Results First Submitted QC: 2011-12-21
• Last Update Submitted: 2011-12-21
• Results First Posted: 2012-01-27
• Last Update Posted: 2012-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bioequivalence and Food effect	desvenlafaxine succinate sustained release	-

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)	Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose	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).
Maximum Plasma Concentration (Cmax)	Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose	Cmax measured as nanograms divided by milliliters (ng/mL).

Secondary Outcome Measures

Name	Time	Method
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose
Terminal Elimination Half-life (t 1/2)	Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose	Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)	Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose	Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUClast)	Day 1 of Periods 1, 2, 3, and 4: pre-dose, 0 hour, and 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post-dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium