Back to resultsStudy Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Primary Purpose
Depression, Depressive Disorder, Depressive Disorder, Major
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
desvenlafaxine SR
desipramine
duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Healthy
Eligibility Criteria
Healthy men and women between 18 to 55 years of age. Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs and a 12-lead electrocardiogram. History of being a nonsmoker for a least 1 year.
Sites / Locations
Outcomes
Primary Outcome Measures
The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
Secondary Outcome Measures
Full Information
NCT ID
NCT00366652
First Posted
August 17, 2006
Last Updated
May 25, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00366652
Brief Title
Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Official Title
A Randomized, Open-Label, Crossover, Drug Interaction Study to Evaluate the Effects of DVS SR And Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Depressive Disorder, Major
Keywords
Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
desvenlafaxine SR
Intervention Type
Drug
Intervention Name(s)
desipramine
Intervention Type
Drug
Intervention Name(s)
duloxetine
Primary Outcome Measure Information:
Title
The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
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
Healthy men and women between 18 to 55 years of age.
Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs and a 12-lead electrocardiogram.
History of being a nonsmoker for a least 1 year.
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
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
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