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Mobic

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment57
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00649077Fasting Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mgPHASE1 COMPLETED 30Aug 1, 2004Sep 1, 2004Apr 24, 20241 United States
NCT00649675Food Study of Meloxicam Tablets 15 mg and Mobic® Tablets 15 mgPHASE1 COMPLETED 27Aug 1, 2004Sep 1, 2004Apr 24, 20241 United States
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Study Endpoints
Primary Endpoints
Bioequivalence
within 30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMeloxicam Tablets 15 mg
2ACTIVE_COMPARATORMobic® Tablets 15 mg
Interventions
NameTypeDescription
Meloxicam Tablets 15 mgDRUG15mg, single dose fasting
Mobic® Tablets 15 mgDRUG15mg, single dose fasting
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administrati...

Countries:United States
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