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Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00329186
First received: May 23, 2006
Last updated: February 6, 2013
Last verified: July 2009
  Purpose

The purpose of this study is to determine if the relative difference in PK between extensive metabolizers (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: desvenlafaxine SR
Drug: venlafaxine ER
Phase 3

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, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary objective is to determine if the relative difference in PK between EMs and PMs is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.

Enrollment: 14
Study Start Date: May 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  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 no clinically significant abnormalities on 12-lead electrocardiogram (ECG)
  • History of nonsmoker for at least 1 year

Exclusion Criteria:

  • Presence or history of any disorder or significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure), or psychiatric disease that may prevent the completion of the study
  • Known or suspected alcohol abuse or consumption of more than 2 standard units per day within past 6 months or known or suspected abuse of prohibited drugs or other substances
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329186

Locations
United States, Kansas
Wichita, Kansas, United States, 67207
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 by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00329186     History of Changes
Other Study ID Numbers: 3151A1-901
Study First Received: May 23, 2006
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Healthy Subjects
Major Depressive Disorder
Depression
Cytochrome P-450 CYP2D6
Pharmacokinetics
Health

Additional relevant MeSH terms:
O-desmethylvenlafaxine
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014