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

NCT00329147 — Phase 3, Completed, 20 participants, Wyeth is now a wholly owned subsidiary of Pfizer

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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

RegistryNCT00329147
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, crossover, masking: none, treatment
Enrollment20 (Estimated)
SponsorWyeth is now a wholly owned subsidiary of Pfizer (Industry)
ConditionsDepression
Interventionsdesvenlafaxine SR, desipramine, paroxetine (Drug)
Datesstart 2006-05-01, completion 2006-06-01, first posted 2006-05-24, last updated 2007-12-07
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Depression All trials of desvenlafaxine SR All trials of desipramine

-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.

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+Arms and interventions

  • desvenlafaxine SR (Drug)
  • desipramine (Drug)
  • paroxetine (Drug)

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to 55 Years, 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.

+Locations (1)

FacilityCityCountryStatus
Neptune City, New JerseyUnited States

+Investigators

  • Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer