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Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)

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ClinicalTrials.gov Identifier: NCT00440427
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to healthy subjects.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Desvenlafaxine Sustained Release (DVS SR) Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Single-Dose Parallel Group Study of the Pharmacokinetic Profile, Safety, and Tolerability of 25- and 50-mg Desvenlafaxine Sustained Release (DVS SR) in Healthy Subjects
Study Start Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Safety


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Men or non-pregnant, non-lactating women
  • Body mass index 18 - 30 kg/m2
  • Body weight greater than or equal to 60kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440427


Locations
United States, Massachusetts
Boston, Massachusetts, United States, 02135
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier: NCT00440427     History of Changes
Other Study ID Numbers: 3151A2-1201
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Major Depressive Disorder
MDD

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs