Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers
A Randomized, Open-Label, Single Dose, Four Way Cross-Over Bioavailability Study Comparing Three Modified Release Formulations Of Apixaban Tablets To Apixaban Immediate Release Tablets In Healthy Volunteers
2 other identifiers
interventional
16
1 country
1
Brief Summary
To estimate the pharmacokinetics of apixaban when administered as three different modified release formulation tablets relative to that when apixaban is administered as an immediate release tablet
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 Jun 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 3, 2009
CompletedFirst Posted
Study publicly available on registry
June 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedAugust 25, 2009
August 1, 2009
2 months
June 3, 2009
August 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½)
96 hours
Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs, physical examinations, and ECGs.
per treatment period of 96 hours
Study Arms (1)
Apixaban Cross-over
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Healthy male or female patients
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
You may not qualify if:
- Any condition possibly affecting drug absorption
- History or evidence of abnormal bleeding or clotting disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Conditions
Condition 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
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 3, 2009
First Posted
June 5, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 25, 2009
Record last verified: 2009-08