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Experimental paracetamol formulation

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01476189A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol FormulationsPHASE1 COMPLETED 28 — — Nov 1, 2009Dec 1, 2009Nov 24, 20141 United States
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Study Endpoints
Primary Endpoints
Bioequivalence as measured by Area Under the Curve (AUC)
last 24 hours of dosing
Secondary Endpoints
Time duration at or above minimal therapeutic plasma paracetamol concentration
last 24 hours of dosing
To assess pharmacokinetic parameters (Cmax, AUC, Tmax and Kel)
last 24 hours of dosing
Adverse events
Baseline to 72 hours post dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Experimental paracetamol formulationEXPERIMENTALtest formulation
Marketed paracetamolACTIVE_COMPARATORMarketed paracetamol
Higher dose marketed paracetamolACTIVE_COMPARATORhigher dose marketed paracetamol
Interventions
NameTypeDescription
Experimental paracetamol formulationDRUGexperimental
Marketed paracetamolDRUGMarketed paracetamol
Higher dose marketed paracetamolDRUGHigher dose marketed paracetamol
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination. Exclusion Criteria: * Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visi...

Countries:United States
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