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Marketed paracetamol

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 Trials2
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01540721Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® ExtendPHASE1 COMPLETED 28 — — Dec 1, 2009Dec 1, 2009Nov 24, 20141 United States
NCT01540734Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®PHASE1 COMPLETED 28 — — Dec 1, 2009Dec 1, 2009Nov 24, 20141 United States
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Study Endpoints
Primary Endpoints
Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state
baseline to 12 hours
Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax
baseline to 12 hours
To compare bioavailability as measured by Area under the Curve in both fed and fasted states
Visit 1 through Visit 3 (Day 13)
To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax
Visit 1 through Visit 3 (Day 13)
Secondary Endpoints
To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)
baseline to 12 hours
To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)
Visit 1 through Visit 3 (Day 13)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Experimental paracetamol formulationEXPERIMENTALExperimental formulation
Marketed paracetamolACTIVE_COMPARATORMarketed formulation
Interventions
NameTypeDescription
Marketed paracetamolDRUGmarketed formulation
Experimental paracetamol formulationDRUGExperimental formulation
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination Exclusion Criteria: * Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs ...

Countries:United States
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