Recent Updates
Recently added Catalysts

Loxoprofen

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Mar 12, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00676117Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese MalesPHASE1 COMPLETED 30 — — Apr 1, 2008Jul 1, 2008Mar 12, 20091 Japan
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
pharmacokinetic profile of D961H during repeated administration with and without co-administration of loxoprofen and pharmacokinetic profile of loxoprofen during repeated administration with and without co-administration of D961H, assessing plasma conc.
5-7 days after the last dose of study medication is given
Secondary Endpoints
The safety of D961H with and without coadministration of loxoprofen by assessment of adverse events, clinical laboratory tests (clinical chemistry, haematology, urinalysis and haemoccult test), ECG, blood pressure, pulse rate and body temperature
5-7 days after the last dose of study medication is given
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Esomeprazole (D961H)DRUG20mg
LoxoprofenDRUG60mg tablet
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Japanese male * Body Mass Index (BMI=weight/height2) 19-27 (kg/m2) * Body weight 50-80 kg Exclusion Criteria: * Past or present NSAIDs induced asthma, hepatic dysfunction, peptic ulcer or blood disorders * Significant clinical illness from the 2 weeks preceding the p...

Countries:Japan
Unlock Eligibility Criteria