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Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Clinical Research Institute
Wichita, Kansas, 67211 United States
Contact
1-800-718-1021
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 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.

- Subjects have to be either extensive CYP2D6 metabolizers with a normal complement of 1
or 2 fully active enzyme gene alleles or poor CYP2D6 metabolizers (lack of active
enzyme gene alleles) via genetic testing of a blood sample.

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

- 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.

NCT00727064
Pfizer
Completed
Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects

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Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg 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 Pharmacokinetics (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 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
  • Drug: Venlafaxine Extended Release (VEN ER)
  • Active Comparator: DVS/VEN
    Interventions:
    • Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
    • Drug: Venlafaxine Extended Release (VEN ER)
  • Active Comparator: VEN/DVS
    Interventions:
    • Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
    • Drug: Venlafaxine Extended Release (VEN ER)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2008
August 2008   (Final data collection date for primary outcome measure)

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.
  • Subjects have to be either extensive CYP2D6 metabolizers with a normal complement of 1 or 2 fully active enzyme gene alleles or poor CYP2D6 metabolizers (lack of active enzyme gene alleles) via genetic testing of a blood sample.

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.
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
 
 
NCT00727064
3151A1-4414
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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
May 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021



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