Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: desvenlafaxine SR (Drug); desipramine (Drug); paroxetine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Neptune, New Jersey 07753, United States
Additional Information
Starting date: May 2006
Ending date: June 2006
Last updated: December 6, 2007
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