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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01190514
First received: August 24, 2010
Last updated: December 21, 2011
Last verified: December 2011
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01190514     History of Changes
Other Study ID Numbers: B2061035
Study First Received: August 24, 2010
Results First Received: December 21, 2011
Last Updated: December 21, 2011
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Pfizer:
DVS SR
healthy
Bioequivalence study

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
O-desmethylvenlafaxine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014