NCT00581451CompletedPhase 1
A 3-Part, Randomized, Multiple-Dose, Sequential Design Study of Bifeprunox in Healthy Subjects in Order to Establish a Titration Regimen With an Improved Tolerability Profile
Wyeth is now a wholly owned subsidiary of Pfizer0 sites144 target enrollmentStarted: October 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 144
- Primary Endpoint
- Tolerability
Study Overview
Brief Summary
Safety and tolerability study in healthy volunteers
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A
Experimental
bifeprunox 25 day
Intervention: bifeprunox (Drug)
B
Experimental
bifeprunox 14 day
Intervention: bifeprunox (Drug)
C
Experimental
bifeprunox 14 day
Intervention: bifeprunox (Drug)
D
Experimental
bifeprunox 9 day
Intervention: bifeprunox (Drug)
Outcomes
Primary Outcomes
Tolerability
Time Frame: 28 days
Secondary Outcomes
- Safety(28 days)
Investigators
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