A Randomized, Open-Label, Cross-Over Drug Interaction Study to Evaluate the Effects of Desvenlafaxine (DVS SR) and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

Wyeth is now a wholly owned subsidiary of Pfizer0 sites20 target enrollmentMay 2006

ConditionsDepression

Drugsdesvenlafaxine SR desipramine paroxetine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Depression
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 20
Primary Endpoint: The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

June 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion 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 12-lead electrocardiogram (ECG)
•History of being a nonsmoker for at least 1 year Other inclusions apply.

Exclusion Criteria

•Presence or history of any disorder or significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic condition, and any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure) or psychiatric disease
•Known or suspected alcohol abuse or consumption of more than 2 standard units per day within the past 6 months
•Use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day-1 until the end of the study Other exclusions apply.

Outcomes

Primary Outcomes

The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.