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Paracetamol formulation 1

Phase 1

Healthy Volunteer | Small molecule | Other |GSK plc|Last Updated: Mar 13, 2012

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01551836At What Time Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed FormulationsPHASE1 COMPLETED 12Jun 1, 2009Jun 1, 2009Mar 13, 20121 United Kingdom
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Study Endpoints
Primary Endpoints
Mean time to therapeutic levels of plasma concentration
within a single day
Secondary Endpoints
Mean plasma concentrations
within a single day
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Paracetamol formulation 1OTHERHigher dose level of marketed paracetamol (compared to the other dosage arm)
Paracetamol formulation 2OTHERLower paracetamol concentrations
Interventions
NameTypeDescription
Paracetamol formulation 1DRUGformulation 1
Paracetamol formulation 2DRUGFormulation 2
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males in good general heatlh and Body Mass Index between 19-28 kg/m2 Exclusion Criteria: * Disease 1. Current liver impairment, renal impairment, history of or active gastrointestinal ulcers, uncontrolled hypertension, haemophilia or other bleeding disorders. 2. Current...

Countries:United Kingdom
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