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Voltaren

Phase 1

Inflammation | Small molecule | Other |Novartis AG|Last Updated: Mar 28, 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_CONTROLLED
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00913224To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated TabletsPHASE1 COMPLETED 38Apr 1, 1993Apr 1, 1993Mar 28, 2017 -
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Study Endpoints
Primary Endpoints
Bioequivalence based on AUC and Cmax
17 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDiclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)
2ACTIVE_COMPARATORVoltaren 50 mg Tablets (Geigy Pharmaceuticals)
Interventions
NameTypeDescription
Diclofenac Sodium 50 mg Tablets (Geneva Pharmaceuticals, Inc)DRUG -
Voltaren 50 mg Tablets (Geigy Pharmaceuticals)DRUG -
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Eligibility Criteria
Age Range18 Years — 41 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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