Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
A Phase 1, Open-Label, Randomized, 3-Way Crossover Study In Healthy Subjects To Estimate The Pharmacokinetics Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
1 other identifier
interventional
14
1 country
1
Brief Summary
This study will test two different formulations. The results will be used to select formulation for phase 3.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2009
Shorter than P25 for phase_1
1 active site
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
First Submitted
Initial submission to the registry
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJuly 8, 2009
July 1, 2009
2 months
March 12, 2009
July 6, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
AUC inf, Cmax
2 days
Secondary Outcomes (1)
Adverse events
2 days
Study Arms (1)
PF-00868554
EXPERIMENTALInterventions
Single dose of 750 mg PF-00868554 as a solution and tablets.
Eligibility Criteria
You may qualify if:
- Healthy volunteers.
You may not qualify if:
- Standard for healthy volunteers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, 1070, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 12, 2009
First Posted
March 13, 2009
Study Start
April 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
July 8, 2009
Record last verified: 2009-07