Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and Females

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: desvenlafaxine succinate SR; Other: Placebo

• Registration Number: NCT00818155
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and the effects of the drug will also be evaluated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-23
• Study Start: 2009-01
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
desvenlafaxine succinate SR	desvenlafaxine succinate SR	desvenlafaxine succinate SR
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results.	2 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics as evaluated from blood and urine concentrations of desvenlafaxine	2 months