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Nimesulide

Phase 1

Pain | Small molecule | Pain |GSK plc|Last Updated: Jun 12, 2017

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01745614Bioequivalence Study of Nimesulide 100 mg TabletsPHASE1 COMPLETED 28 — — Jul 18, 2010Jul 26, 2010Jun 12, 2017 - —
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Study Endpoints
Primary Endpoints
Peak Plasma Concentration (CMAX) of nimesulide
0.0, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18.0 and 24.0 postdosage

Pharmacokinetics

Area under the plasma concentration versus time curve (AUC) of nimesulide
0.0, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 15.0, 18.0 and 24.0 postdosage

Pharmacokinetics

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
A (reference)/ B (test)EXPERIMENTALinitial administration of reference and cross-over to test
B (test)/ A (reference)EXPERIMENTALinitial administration of test and cross-over to reference
Interventions
NameTypeDescription
Nimesulide 100 mg tabletsDRUGReference product
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice. Healthy, between 18 and 40 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; he...

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