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

Phase 1

Completed

• Conditions: Vasomotor Symptoms

• Registration Number: NCT00397176
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-07
• Study First Submitted QC: 2006-11-07
• Study First Posted: 2006-11-08
• Study Completion: 2007-02
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety, Tolerability, PK