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Naproxen Tables, 375

Phase 1

Rheumatoid Arthritis | 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 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 Arthritis
NCT0095943934
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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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Competitive Landscape -Rheumatoid Arthritis 91 trials

Top 20 of 27 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV5PHASE3Adalimumab, Upadacitinib
Bristol-Myers Squibb CompanyBMY6PHASE3Abatacept, Adalimumab, Methotrexate
Eli Lilly and CompanyLLY4PHASE3Baricitinib, Tocilizumab
Johnson & JohnsonJNJ1PHASE3Guselkumab
AstraZeneca PLCAZN4PHASE2AZD1163
Novartis AG Sponsored ADRNVS3PHASE2VAY736 PFS, VAY736 AI
Merck & Co., Inc.MRK2PHASE2Tulisokibart, Methotrexate
AnaptysBio, Inc.ANAB1PHASE2Rosnilimab
Spyre Therapeutics, IncSYRE1PHASE2SPY002-072
Sanofi SA Sponsored ADRSNY2PHASE2Sarilumab SAR153191
Immunovant IncIMVT1PHASE2IMVT-1402
XBiotech, Inc.XBIT1PHASE2Natrunix, Methotrexate
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Artiva Biotherapeutics, Inc.ARTV2PHASE2Allogeneic NK Cells
Gilead Sciences, Inc.GILD1PHASE1GS-0151
Stryker CorporationSYK5N/AUndisclosed
Zimmer Biomet Holdings, Inc.ZBH29N/AUndisclosed
Cullinan Therapeutics, Inc.CGEM1PHASE1CLN-978
Sonoma Pharmaceuticals, Inc.SNOA2PHASE1SBT777101
Xencor, Inc.XNCR1PHASE1Plamotamab
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