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

This study has been completed.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00397176

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 I

Drug Information available for: Succinic acid Desvenlafaxine Succinate Desvenlafaxine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title:	Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects

Further study details as provided by Wyeth:

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

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

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

Study placed in the following topic categories:

O-desmethylvenlafaxine
Healthy

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Agents
Antidepressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009