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Naproxen Tables, 375

Phase 1

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

Target and mechanism

Molecular targetPTGS2, PTGS1
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL154

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

Naproxen Tables, 375 · 1 trial · 2 indications

Phase 1 1
NCT00959439Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)Rheumatoid Arthritis
COMPLETED34 Analytics
PHASE1COMPLETED
Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

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

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALNaproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)
2ACTIVE_COMPARATORNaproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

Interventions

NameTypeDescription
Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.)DRUG -
Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)DRUG -
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Eligibility Criteria

Age Range21 Years to 50 Years
SexALL
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 Naproxen Tables, 375

What is Naproxen Tablets, 375 used for?

Naproxen Tablets, 375 is a 375 mg delayed-release oral formulation of naproxen studied for rheumatoid arthritis. It is also referenced in osteoarthritis research. The drug is a small molecule in the immunology therapeutic area and has been evaluated in a Phase 1 relative bioavailability study.

What does Naproxen Tablets, 375 target?

Naproxen Tablets, 375 targets PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. It acts as an inhibitor of these enzymes. This target class is consistent with the drug's development for inflammatory joint conditions such as rheumatoid arthritis.

Who is developing Naproxen Tablets, 375?

Novartis AG (ticker: NVS) is the developer of Naproxen Tablets, 375. The alternative name Naproxen Delayed Release Tablets, 375 is associated with Gevena Pharmaceuticals, Inc. The asset is a small molecule in the immunology therapeutic area.

What phase is Naproxen Tablets, 375 in?

Naproxen Tablets, 375 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes one completed trial with 34 participants.

What clinical trials is Naproxen Tablets, 375 in?

Naproxen Tablets, 375 has been studied in one completed Phase 1 trial, NCT00959439, titled Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg). The trial enrolled 34 participants, was randomized, active-controlled, and included healthy volunteers. It evaluated rheumatoid arthritis and osteoarthritis conditions.

Is Naproxen Tablets, 375 the same as Naproxen Delayed Release Tablets, 375?

Yes, Naproxen Tablets, 375 is also known as Naproxen Delayed Release Tablets, 375, associated with Gevena Pharmaceuticals, Inc. Both names refer to the same 375 mg delayed-release naproxen formulation developed by Novartis AG for rheumatoid arthritis.