Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Phase 3
Completed
- Conditions
- Depression
- Registration Number
- NCT00329147
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The purpose of this study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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 12-lead electrocardiogram (ECG)
- History of being a nonsmoker for at least 1 year Other inclusions apply.
Exclusion Criteria
- Presence or history of any disorder or significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic condition, and any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure) or psychiatric disease
- Known or suspected alcohol abuse or consumption of more than 2 standard units per day within the past 6 months
- 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 Other exclusions apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method The primary outcome of the study is to evaluate the effects of multiple doses of DVS SR and paroxetine on the pharmacokinetics of a single dose of desipramine in healthy subjects.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the mechanism of CYP2D6 inhibition by DVS SR and paroxetine in desipramine metabolism?
How does DVS SR compare to paroxetine in modulating desipramine pharmacokinetics in healthy subjects?
Are there specific biomarkers that correlate with desipramine response when co-administered with DVS SR or paroxetine?
What are the potential drug-drug interaction risks of combining DVS SR/paroxetine with desipramine in depression treatment?
How do DVS SR and paroxetine influence desipramine plasma concentrations via CYP enzyme pathways?