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

This study has been completed.

First Received: August 17, 2006 Last Updated: May 25, 2007 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00366652

Purpose

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.

Condition	Intervention	Phase
Depression Depressive Disorder Depressive Disorder, Major	Drug: desvenlafaxine SR Drug: desipramine Drug: duloxetine	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Desipramine Desipramine hydrochloride Desvenlafaxine Duloxetine Duloxetine hydrochloride

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 duloxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.

Estimated Enrollment:	20
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2006

Eligibility

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

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 a 12-lead electrocardiogram.
History of being a nonsmoker for a least 1 year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366652

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:	3151A1-401
Study First Received:	August 17, 2006
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00366652 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Healthy

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Healthy
Depressive Disorder
Desipramine
Serotonin Uptake Inhibitors

Serotonin
Duloxetine
Behavioral Symptoms
Antidepressive Agents, Tricyclic
Dopamine
Mental Disorders
O-desmethylvenlafaxine
Mood Disorders
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Desipramine
Duloxetine
Pathologic Processes
O-desmethylvenlafaxine
Mental Disorders

Therapeutic Uses
Antidepressive Agents
Disease
Depression
Enzyme Inhibitors
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Antidepressive Agents, Tricyclic
Serotonin Agents
Mood Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009