Status:
COMPLETED
Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Depression
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00329147
Start Date
May 1 2006
End Date
June 1 2006
Last Update
December 7 2007
Active Locations (1)
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1
Neptune City, New Jersey, United States, 07753