Back to resultsPhase 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)
Primary Purpose
Depression - Major Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
desvenlafaxine succinate sustained release
desvenlafaxine succinate sustained release
desvenlafaxine succinate sustained release
desvenlafaxine succinate sustained release
Sponsored by
About this trial
This is an interventional treatment trial for Depression - Major Depressive Disorder focused on measuring DVS SR, healthy, Bioequivalence study
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bioequivalence and Food effect
Arm Description
Outcomes
Primary Outcome Measures
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).
Maximum Plasma Concentration (Cmax)
Cmax measured as nanograms divided by milliliters (ng/mL).
Secondary Outcome Measures
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Terminal Elimination Half-life (t 1/2)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01190514
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression - Major Depressive Disorder
Keywords
DVS SR, healthy, Bioequivalence study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bioequivalence and Food effect
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
desvenlafaxine succinate sustained release
Other Intervention Name(s)
DVS-233 SR, Pristiq
Intervention Description
Two tablets of 25 mg, single administration, under fed condition
Intervention Type
Drug
Intervention Name(s)
desvenlafaxine succinate sustained release
Other Intervention Name(s)
DVS-233 SR, Pristiq
Intervention Description
One tablet of 50 mg, single administration, under fed condition
Intervention Type
Drug
Intervention Name(s)
desvenlafaxine succinate sustained release
Other Intervention Name(s)
DVS-233 SR, Pristiq
Intervention Description
Two tablets of 25 mg, single administration, under fast condition
Intervention Type
Drug
Intervention Name(s)
desvenlafaxine succinate sustained release
Other Intervention Name(s)
DVS-233 SR, Pristiq
Intervention Description
One tablet of 50 mg, single administration, under fast condition
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration-time Profile From Time 0 to 48 Hours (AUC48)
Description
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).
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
Title
Maximum Plasma Concentration (Cmax)
Description
Cmax measured as nanograms divided by milliliters (ng/mL).
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
Secondary Outcome Measure Information:
Title
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
Title
Terminal Elimination Half-life (t 1/2)
Description
Terminal elimination (plasma decay) half-life is the time measured for the plasma concentration to decrease by one half.
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
Title
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)
Description
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 - ∞).
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
B-1070
Country
Belgium
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2061035&StudyName=Phase%201%20Study%20To%20Test%20the%20Bioequivalence%20Between%20Two%2025%20mg%20Tablets%20vs.%20One%2050%20mg%20Tablet%20Under%20Fast/Fed%20Condition%20and%20Evaluate%20Food
Description
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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)
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