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Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway

Last updated on May 11, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder, Diabetic Neuropathies, Fibromyalgia, Vasomotor Symptoms
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy men and nonlactating and nonpregnant women of nonchildbearing potential aged
from 18 to 45 years.

- Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.

- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

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

- History of bronchial asthma, of seizure disorder (other than a single childhood
febrile seizure)and of any clinically important drug allergy and any known allergy to
desvenlafaxine, venlafaxine, paroxetine, codeine, or any of the non-active excipients
in the dosage forms.

- Use of any CYP2D6 inhibitors or inducers within 30 days before test article
administration.

- Demonstration of a positive orthostatic test at screening.

NCT00456898
Pfizer
Completed
Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway

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Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
A Randomized, Open-Label, 3-Period Crossover Study to Evaluate the Effect of Multiple Doses of DVS SR and Paroxetine on the CYP2D6 Biotransformation of Codeine to Morphine in Healthy Subjects.
To evaluate the effects of multiple oral doses of desvenlafaxine sustained release (DVS SR) and paroxetine on the biotransformation of codeine to morphine in healthy subjects. To assess the safety and tolerability of DVS SR and paroxetine when coadministered with codeine to healthy subjects.
This is a randomized, open-label, inpatient/outpatient, 3-period crossover study in healthy subjects.The study will consist of 3 treatment periods. In treatment period 1, subjects will be randomly assigned on study day 1. A single 60-mg dose of codeine will be administered to all subjects. In periods 2 and 3, subjects will receive either DVS SR 100 mg/day or paroxetine 20 mg/day until the steady state is reached. At steady state, subjects will receive codeine 60 mg concomitantly with either DVS SR 100 mg or paroxetine 20 mg, depending on the treatment sequence to which they are assigned. DVS SR 100 mg or paroxetine 20 mg administration will continue for an additional 2 days. In treatment period 3, subjects will receive the alternative treatment sequence.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Depressive Disorder, Major
  • Diabetic Neuropathies
  • Fibromyalgia
  • Vasomotor Symptoms
  • Drug: desvenlafaxine sustained release (DVS SR)
  • Drug: Paroxetine
  • Drug: Codeine
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2007
Not Provided

Inclusion criteria:

  • Healthy men and nonlactating and nonpregnant women of nonchildbearing potential aged from 18 to 45 years.
  • Body mass index in the range of 18 to 30 kg/m2 and body weight ?50 kg.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion criteria:

  • History of bronchial asthma, of seizure disorder (other than a single childhood febrile seizure)and of any clinically important drug allergy and any known allergy to desvenlafaxine, venlafaxine, paroxetine, codeine, or any of the non-active excipients in the dosage forms.
  • Use of any CYP2D6 inhibitors or inducers within 30 days before test article administration.
  • Demonstration of a positive orthostatic test at screening.
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00456898
3151A1-1203
Not Provided
Not Provided
Not Provided
Not Provided
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
December 2007

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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