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Apixaban IR

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Apixaban IR · 1 trial · 1 indication

Phase 1 1
NCT00914641Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy VolunteersThrombosis
COMPLETED16 Analytics
PHASE1COMPLETED
Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers
ThrombosisUnlock trial analytics

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 to 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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Frequently asked questions about Apixaban IR

What is Apixaban IR used for?

Apixaban IR is an investigational small molecule being developed for the treatment of thrombosis, a condition involving blood clot formation. It is currently in Phase 1 clinical development and has not yet been approved by regulatory authorities.

Who makes Apixaban IR?

Apixaban IR is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for the treatment of thrombosis.

What phase is Apixaban IR in?

Apixaban IR is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for the treatment of thrombosis, a condition involving abnormal blood clot formation.

What clinical trials is Apixaban IR in?

Apixaban IR has one completed clinical trial, identified as NCT00914641, which was a Phase 1 bioavailability study comparing modified release to immediate release apixaban tablets in healthy volunteers. The trial enrolled 16 participants and was conducted in the United States.

Is Apixaban IR the same as apixaban?

Apixaban IR is a specific formulation of apixaban, an anticoagulant medication. The 'IR' designation indicates an immediate release formulation, which was studied in a Phase 1 bioavailability trial (NCT00914641) comparing it to a modified release version in healthy volunteers.