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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00397176
First received: November 7, 2006
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety, Tolerability, PK

Estimated Enrollment: 32
Study Start Date: November 2006
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00397176     History of Changes
Other Study ID Numbers: 3151A2-1200
Study First Received: November 7, 2006
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
O-desmethylvenlafaxine
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014