Status:
COMPLETED
Study Evaluating the Potential of DVS SR to Inhibit the CYP2D6 Pathway
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Depressive Disorder, Major
Diabetic Neuropathies
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 ass...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00456898
Start Date
January 1 2007
End Date
March 1 2007
Last Update
December 28 2007
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