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Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women

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ClinicalTrials.gov Identifier: NCT00397176
Recruitment Status : Completed
First Posted : November 8, 2006
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.

Condition or disease Intervention/treatment Phase
Vasomotor Symptoms Drug: desvenlafaxine succinate sustained release (DVS SR) Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects
Study Start Date : November 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Safety, Tolerability, PK


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, first-generation (born in Japan, living in the US for less than 5 years)
  • Japanese female subjects

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): NCT00397176


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: NCT00397176     History of Changes
Other Study ID Numbers: 3151A2-1200
First Posted: November 8, 2006    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
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