Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women
Ascending, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of DVS SR Administered Orally to Healthy Japanese Female Subjects
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release (DVS SR) in healthy Japanese female subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2006
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 7, 2006
CompletedFirst Posted
Study publicly available on registry
November 8, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedDecember 28, 2007
December 1, 2007
November 7, 2006
December 19, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Safety, Tolerability, PK
Interventions
Eligibility Criteria
You may qualify if:
- Healthy, first-generation (born in Japan, living in the US for less than 5 years)
- Japanese female subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 7, 2006
First Posted
November 8, 2006
Study Start
November 1, 2006
Study Completion
February 1, 2007
Last Updated
December 28, 2007
Record last verified: 2007-12