Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366652
• Other study ID #: 3151A1-401
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2006
• Last updated: May 25, 2007
• Start date: September 2006
• Est. completion date: September 2006

Study information

• Verified date: May 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

1. Healthy men and women between 18 to 55 years of age.

2. 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.

3. History of being a nonsmoker for a least 1 year.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Drug:
• desvenlafaxine SR

• desipramine

• duloxetine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.