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

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Depression

Treatments

Drug: desvenlafaxine SR
Drug: desipramine
Drug: paroxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00329147
3151A1-900

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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