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

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NCT00329186

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Study Location
Wichita, Kansas, 67207, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: desvenlafaxine SR
  • Drug: venlafaxine ER
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2006)		14
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00329186
Other Study ID Numbers  ICMJE 3151A1-901
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

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