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Indocin

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Indocin · 1 trial · 1 indication

Phase 1 1
NCT00858195A Relative Bioavailability Study of 75mg Indomethacin Extended-Release CapsulesInflammation
COMPLETED36 Analytics
PHASE1COMPLETED
A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules
InflammationUnlock trial analytics

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 to 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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Frequently asked questions about Indocin

What is Indocin used for?

Indocin is used for inflammation. It is a small molecule drug being developed by Novartis AG for the treatment of inflammation, which falls under the therapeutic area of immunology. The drug is currently in Phase 1 clinical development.

Who makes Indocin?

Indocin is developed by Novartis AG, a company traded under the ticker symbol NVS. The drug is a small molecule being investigated for the treatment of inflammation. It is currently in Phase 1 clinical development.

What phase is Indocin in?

Indocin is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of inflammation. The drug has completed one Phase 1 trial, and it is not yet approved by regulatory authorities.

What clinical trials is Indocin in?

Indocin has one completed clinical trial, NCT00858195, titled 'A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules'. This Phase 1 trial enrolled 36 participants and was an active-controlled, randomized study involving healthy volunteers.

Is Indocin the same as indomethacin?

Indocin is a brand name for indomethacin. The clinical trial NCT00858195 studied 75mg indomethacin extended-release capsules, which are the formulation of Indocin. The drug is being developed by Novartis AG for inflammation.