NCT00440427

Brief Summary

To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

February 23, 2007

Last Update Submit

December 3, 2007

Conditions

Depressive Disorder, Major

Keywords

Major Depressive DisorderMDD

Outcome Measures

Primary Outcomes (1)

  • Safety

Interventions

Desvenlafaxine Sustained Release (DVS SR)DRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
* Men or non-pregnant, non-lactating women * Body mass index 18 - 30 kg/m2 * Body weight greater than or equal to 60kg

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Boston, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 27, 2007

Study Start

February 1, 2007

Study Completion

February 1, 2007

Last Updated

December 5, 2007

Record last verified: 2007-12

Locations

US(1)