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

This study has been completed.

First Received: May 23, 2006 Last Updated: December 6, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00329147

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: desvenlafaxine SR Drug: desipramine Drug: paroxetine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Desipramine Desipramine hydrochloride Paroxetine Paroxetine hydrochloride Desvenlafaxine Paroxetine Mesylate Desvenlafaxine Succinate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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.

Estimated Enrollment:	20
Study Start Date:	May 2006
Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329147

Locations

United States, New Jersey

Neptune, New Jersey, United States, 07753

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3151A1-900
Study First Received:	May 23, 2006
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00329147 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Healthy Subjects
Major Depressive Disorder
Depression

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Enzyme Inhibitors
Depressive Disorder
Desipramine
Serotonin Uptake Inhibitors

Paroxetine
Pharmacologic Actions
Behavioral Symptoms
Antidepressive Agents, Tricyclic
Serotonin Agents
Mental Disorders
O-desmethylvenlafaxine
Therapeutic Uses
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 09, 2009