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Apixaban sprinkle

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jan 23, 2020

Target and mechanism

ModalitySmall molecule

Also known as Drug: Apixaban sprinkle capsules, Drug: Apixaban sprinkle

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

Apixaban sprinkle · 1 trial · 1 indication

Phase 1 1
NCT03509883Bioavailability of Apixaban Sprinkle Compared to Apixaban CapsulesHealthy Volunteers
COMPLETED94 Analytics
PHASE1COMPLETED
Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules
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Study Endpoints

Primary Endpoints

Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)
Day 1 to Day 8

Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration

AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration
Day 1 to Day 8

Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time

AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time
Day 1 to Day 8

Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time

Secondary Endpoints

Tmax - Time of Maximum Observed Plasma Concentration
Day 1 to Day 8
T-Half - Terminal Plasma Half Life.
Day 1 to Day 8
Frel - Relative Bioavailability
Day 1 to Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Apixaban sprinkle capsules followed by apixaban tabletsEXPERIMENTALApixaban (BMS-562247) sprinkle capsules followed by apixaban tablets
Apixaban tablets followed by apixaban sprinkle capsulesACTIVE_COMPARATORApixaban (BMS-562247) tablets followed by apixaban sprinkle capsules

Interventions

NameTypeDescription
Drug: Apixaban sprinkle capsulesDRUGSingle dose (25 x 0.1 mg capsules), oral administration
Experimental: Apixaban tablets followed by apixaban sprinkle capsulesDRUGApixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed informed consent form. * Healthy male and female participants determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs (electrocardiograms), vital signs and clinical laboratory determinations. * Women of childb...

Countries:United States
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