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ASA

Phase 1

Ulcers | Small molecule | Other |AstraZeneca PLC|Last Updated: Mar 12, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00688428Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free CombinationPHASE1 COMPLETED 84Apr 1, 2008Apr 1, 2008Mar 12, 2009 -
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Study Endpoints
Primary Endpoints
Samples for measurement of esomeprazole, ASA, and SA concentrations
Day 1 of each period
Secondary Endpoints
Fasting blood samples for determination of clinical chemistry and hematology parameters
screening and follow up visit
urine samples for urinalysis parameters
screening, Period 1, and follow-up visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALcombination capsule of Esomeprazole 40mg + ASA 325mg
2EXPERIMENTALEsomeprazole 40 mg capsule and ASA 325 mg tablet
Interventions
NameTypeDescription
Esomeprazole 40mg/ASA 325mgDRUGcombination capsule, administered as a single oral dose
EsomeprazoleDRUG40mg capsule, administered as a single dose
ASADRUG325mg tablet, administered as a single oral dose
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Eligibility Criteria
Age Range20 Years — 50 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Body mass index of 19-29kg/m2, inclusive * Weight of 50-95kg, inclusive * Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator Exclusion Criteria: * Significant clinical illness within the 2 week...

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Competitive Landscape -Skin Ulcers 3 trials