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Experimental paracetamol

Phase 1

Headache, Tension-Type | Small molecule | Other |GSK plc|Last Updated: Nov 24, 2014

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
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01476176A Pharmacokinetic Study of an Experimental Paracetamol FormulationPHASE1 COMPLETED 30 — — Jul 1, 2009Aug 1, 2009Nov 24, 20141 United States
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Study Endpoints
Primary Endpoints
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence
10 hours
Secondary Endpoints
PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)
10 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Experimental paracetamol formulationEXPERIMENTALexperimental formulation
paracetamol marketed formulationACTIVE_COMPARATORParacetamol marketed formulation
Interventions
NameTypeDescription
Experimental paracetamolDRUGexperimental paracetamol with caffeine
Paracetamol marketed formulationDRUGmarketed formulation containing caffeine
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteer Exclusion Criteria: \-

Countries:United States
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