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)

NCT01190514 | Completed Phase 1 Results

• 1 other identifier: B2061035
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression - Major Depressive Disorder

Keywords

DVS SR; healthy; Bioequivalence study

Outcome Measures

Primary Outcomes (2)

• 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).

  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

• Maximum Plasma Concentration (Cmax)

  Cmax measured as nanograms divided by milliliters (ng/mL).

  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

Secondary Outcomes (4)

• 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

• 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-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

Study Arms (1)

Bioequivalence and Food effect

EXPERIMENTAL

Drug: desvenlafaxine succinate sustained release

Interventions

desvenlafaxine succinate sustained release DRUG

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

Also known as: DVS-233 SR, Pristiq

Bioequivalence and Food effect

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Desvenlafaxine Succinate

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 27, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 27, 2012
• Results First Posted: January 27, 2012

Record last verified: 2011-12

Locations

BE (1)