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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01190514
First Posted: August 27, 2010
Last Update Posted: January 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose

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.


Condition Intervention Phase
Depression - Major Depressive Disorder Drug: desvenlafaxine succinate sustained release Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48) [ Time Frame: 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) [ Time Frame: 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:
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 ]

Enrollment: 41
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bioequivalence and Food effect Drug: desvenlafaxine succinate sustained release
Two tablets of 25 mg, single administration, under fed condition
Other Name: DVS-233 SR, Pristiq
Drug: desvenlafaxine succinate sustained release
One tablet of 50 mg, single administration, under fed condition
Other Name: DVS-233 SR, Pristiq
Drug: desvenlafaxine succinate sustained release
Two tablets of 25 mg, single administration, under fast condition
Other Name: DVS-233 SR, Pristiq
Drug: desvenlafaxine succinate sustained release
One tablet of 50 mg, single administration, under fast condition
Other Name: DVS-233 SR, Pristiq

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190514


Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01190514     History of Changes
Other Study ID Numbers: B2061035
First Submitted: August 24, 2010
First Posted: August 27, 2010
Results First Submitted: December 21, 2011
Results First Posted: January 27, 2012
Last Update Posted: January 27, 2012
Last Verified: December 2011

Keywords provided by Pfizer:
DVS SR
healthy
Bioequivalence study

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs