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Apixaban IR

Phase 1

Thrombosis | Small molecule | Other |Pfizer, Inc.|Last Updated: Aug 25, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00914641Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy VolunteersPHASE1 COMPLETED 16Jun 1, 2009Aug 1, 2009Aug 25, 20091 United States
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Study Endpoints
Primary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Apixaban Cross-overOTHER -
Interventions
NameTypeDescription
Apixaban IRDRUGimmediate release tablet, 10 mg, single dose
Apixaban MR1DRUGmodified release tablet 1, 10 mg, single dose
Apixaban MR2DRUGmodified release tablet 2, 10 mg, single dose
Apixaban MR3DRUGmodified release tablet 3, 10 mg, single dose
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female patients * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 Exclusion Criteria: * Any condition possibly affecting drug absorption * History or evidence of abnormal bleeding or clotting disorder

Countries:United States
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