Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR 50 mg in Healthy Subjects - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00727064

Purpose

The purpose of this study is to determine if the relative difference in PK between extensive metobolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.

Condition	Intervention	Phase
Healthy	Drug: DVS/VEN Drug: VEN/DVS	Phase I

Drug Information available for: Desvenlafaxine Succinate Desvenlafaxine Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Randomized, Open-Label, Two-Period, Parallel Group, Crossover Study to Evaluate the Pharmacokinetics of Venlafaxine Extended-Release and DVS SR in Healthy Subjects Who Are Extensive or Poor Cytochrome P450 2D6 Substrate Metabolizers

Further study details as provided by Wyeth:

Primary Outcome Measures:

To determine if the relative difference in PK between EMs and PMs is the same with desvenlafaxine and venlafaxine when a single dose is administered. [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	14
Study Start Date:	June 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator DVS/VEN	Drug: DVS/VEN
B: Active Comparator VEN/DVS	Drug: VEN/DVS

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 aged 18 to 55 years. 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.

Exclusion Criteria:

Presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease or any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure).
Known or suspected alcohol abuse or consumption of more than 2 standard units per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine) within the past 6 months.
Known or suspected current abuse of prohibited drugs or other substances. Use of any hormonal therapy within 30 days before study day -1 until the end of the partial inpatient confinement period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727064

Locations

United States, Kansas
Clinical Research Institute
Wichita, Kansas, United States, 67211

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3151A1-4414
Study First Received:	July 29, 2008
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00727064
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Healthy Subjects

Study placed in the following topic categories:

O-desmethylvenlafaxine
Venlafaxine
Healthy
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Serotonin Uptake Inhibitors
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009