Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects
NCT00329147
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FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects | |||
Official Title ICMJE | A Randomized, Open-Label, Cross-Over Drug Interaction Study to Evaluate the Effects of Desvenlafaxine (DVS SR) and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Depression | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 20 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | June 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00329147 | |||
Other Study ID Numbers ICMJE | 3151A1-900 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |