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Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00581451
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : July 10, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
Safety and tolerability study in healthy volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: bifeprunox Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: 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
Study Start Date : October 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: A
bifeprunox 25 day
Drug: bifeprunox
oral tablet once daily
Experimental: B
bifeprunox 14 day
Drug: bifeprunox
oral tablet once daily
Experimental: C
bifeprunox 14 day
Drug: bifeprunox
oral tablet once daily
Experimental: D
bifeprunox 9 day
Drug: bifeprunox
oral tablet once daily


Outcome Measures

Primary Outcome Measures :
  1. Tolerability [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy male 18-50 years
  • Nonlactating female 18-50 years
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581451


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581451     History of Changes
Other Study ID Numbers: 3168A2-1005
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009