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

December 19, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

32

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety, Tolerability, PK

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

November 7, 2006

First Submitted That Met QC Criteria

November 7, 2006

First Posted (Estimate)

November 8, 2006

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3151A2-1200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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