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

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ClinicalTrials.gov Identifier: NCT00329186
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

May 23, 2006
May 24, 2006
February 8, 2013
May 2006
June 2007   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00329186 on ClinicalTrials.gov Archive Site
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Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • Drug: desvenlafaxine SR
  • Drug: venlafaxine ER
Not Provided
Preskorn S, Patroneva A, Silman H, Jiang Q, Isler JA, Burczynski ME, Ahmed S, Paul J, Nichols AI. Comparison of the pharmacokinetics of venlafaxine extended release and desvenlafaxine in extensive and poor cytochrome P450 2D6 metabolizers. J Clin Psychopharmacol. 2009 Feb;29(1):39-43. doi: 10.1097/JCP.0b013e318192e4c1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
Same as current
June 2007
June 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00329186
3151A1-901
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP