Back to resultsStudy Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Desvenlafaxine Sustained Release (DVS SR)
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major Depressive Disorder, MDD
Eligibility Criteria
- Men or non-pregnant, non-lactating women
- Body mass index 18 - 30 kg/m2
- Body weight greater than or equal to 60kg
Sites / Locations
Outcomes
Primary Outcome Measures
Safety
Secondary Outcome Measures
Full Information
NCT ID
NCT00440427
First Posted
February 23, 2007
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00440427
Brief Title
Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)
Official Title
A Randomized, Open-Label, Single-Dose Parallel Group Study of the Pharmacokinetic Profile, Safety, and Tolerability of 25- and 50-mg Desvenlafaxine Sustained Release (DVS SR) in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Major Depressive Disorder, MDD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine Sustained Release (DVS SR)
Primary Outcome Measure Information:
Title
Safety
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
Men or non-pregnant, non-lactating women
Body mass index 18 - 30 kg/m2
Body weight greater than or equal to 60kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)
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