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Indocin

Phase 1

Inflammation | Small molecule | Other |Novartis AG|Last Updated: Mar 29, 2017

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00858195A Relative Bioavailability Study of 75mg Indomethacin Extended-Release CapsulesPHASE1 COMPLETED 36Jun 1, 2006Jul 1, 2006Mar 29, 2017 -
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Study Endpoints
Primary Endpoints
Bioequivalence according to US FDA guidelines.
8 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALIndomethacin 75mg ER Capsules
2ACTIVE_COMPARATORIndocin 75mg SR Capsules
Interventions
NameTypeDescription
Indomethacin 75mg Extended-Release Capsules, SandozDRUG -
Indocin 75mg SR CapsulesDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening Exclusion Criteria: * Positive test results for HIV or hepatitis B or C * No allergies to indomethacin or related drugs

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