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Paracetamol fast dissolution

Phase 1

Healthy Subjects | 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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01476215A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric SuspensionsPHASE1 COMPLETED 18 — — Nov 1, 2009Nov 1, 2009Nov 24, 20141 United States
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Study Endpoints
Primary Endpoints
Time to plasma level above therapeutic level
baseline to 8 hours
Secondary Endpoints
General PK parameters (e.g. AUC, Tmax, Cmax)
baseline to 8 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Fast dissolution suspensionEXPERIMENTAL -
Medium dissolution suspensionEXPERIMENTAL -
Slow dissolution suspensionEXPERIMENTAL -
Marketed suspensionACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Paracetamol fast dissolution suspensionDRUG -
Paracetamol medium dissolution suspensionDRUG -
Paracetamol slow dissolution suspensionDRUG -
ParacetamolDRUG -
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Eligibility Criteria
Age Range19 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteer * Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive

Countries:United States
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