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Voltaren

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 Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

Voltaren · 1 trial · 1 indication

Phase 1 1
NCT00913224To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated TabletsInflammation
COMPLETED38 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets
InflammationUnlock trial analytics

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 to 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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Frequently asked questions about Voltaren

What is Voltaren used for?

Voltaren is used for inflammation. It is a small molecule drug being developed by Novartis AG for the treatment of inflammation. The drug is currently in Phase 1 clinical development, with one completed trial involving 38 participants.

Who makes Voltaren?

Voltaren is developed by Novartis AG, a pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The drug is being investigated for its use in treating inflammation.

What phase is Voltaren in?

Voltaren is in Phase 1 clinical development. It has completed one Phase 1 trial, which was an active-controlled study with 38 participants. The drug is still investigational and has not been approved for use.

What clinical trials is Voltaren in?

Voltaren has one completed clinical trial with the identifier NCT00913224, titled 'To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets'. This Phase 1 study enrolled 38 healthy male volunteers aged 18 years and older.

Is Voltaren the same as diclofenac?

Voltaren is a brand name for diclofenac sodium. The clinical trial for Voltaren specifically studied diclofenac sodium 50 mg enteric-coated tablets. The drug is being developed by Novartis AG for inflammation.