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Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects

NCT ID: NCT00329147

Last Updated: 2007-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-06-30

Brief Summary

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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

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Conditions

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Depression

Keywords

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Healthy Subjects Major Depressive Disorder Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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desvenlafaxine SR

Intervention Type DRUG

desipramine

Intervention Type DRUG

paroxetine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Neptune City, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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3151A1-900

Identifier Type: -

Identifier Source: org_study_id