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

This study has been completed.

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

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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 Desvenlafaxine Succinate

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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 is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Healthy

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Desipramine
Duloxetine
O-desmethylvenlafaxine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidepressive Agents, Tricyclic

Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Serotonin Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on February 09, 2012