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

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
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 is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

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

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
Last updated: December 6, 2007

Page last updated: August 23, 2015

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