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Diclofenac Under Fasting Conditions

Phase 1

Inflammation | Small molecule | Immunology |Novartis AG|Last Updated: Mar 28, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Diclofenac Under Fasting Conditions · 2 trials · 1 indication

Phase 1 2
NCT00913887To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting ConditionsInflammation
COMPLETED18 Analytics
NCT00914160To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting ConditionsInflammation
COMPLETED18 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Inflammation
NCT0091388718
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PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Inflammation
NCT0091416018
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Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
32 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDiclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)
2EXPERIMENTALDiclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)
3ACTIVE_COMPARATORVoltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)

Interventions

NameTypeDescription
Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)DRUG -
Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)DRUG -
Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)DRUG -
Diclofenac Sodium 50 mg Tablets Under Fasting Conditions (Geneva Pharmaceuticals, Inc)DRUG -
Diclofenac Sodium 50 mg Tablets Under Fed Conditions (Geneva Pharmaceuticals, Inc)DRUG -
Voltaren 50 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)DRUG -
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Eligibility Criteria

Age Range18 Years to 40 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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