Recent Updates
Recently added Catalysts

Marketed paracetamol

Phase 1

Pain | Small molecule | Pain |GSK plc|Trials Updated: Nov 24, 2014

Marketed paracetamol development status

Highest phase Phase 1
Registered trials 5 across 1 sponsor since Jun 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Marketed paracetamol clinical trials

Marketed paracetamol · 1 trial · 1 indication

Phase 1 1
NCT01592227A Study to Compare Two Paracetamol Formulations.Pain
COMPLETED30 Analytics
PHASE1COMPLETED
A Study to Compare Two Paracetamol Formulations.
PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states
baseline to 10 hours post dose

Secondary Endpoints

Speed of absorption in fasted and semi-fed states
baseline to 10 hours post dose
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Marketed paracetamolACTIVE_COMPARATORMarketed paracetamol
Experimental paracetamol formulationEXPERIMENTALExperimental formulations

Interventions

NameTypeDescription
Marketed paracetamolDRUGMarketed paracetamol
Experimental paracetamol formulationDRUGExperimental paracetamol formulation
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Marketed paracetamol

What is marketed paracetamol used for?

Marketed paracetamol is used for pain. It is a small molecule medicine developed by GSK plc, which trades under the ticker GSK. The clinical program in pain includes one completed Phase 1 trial conducted in the United States.

Who makes marketed paracetamol?

Marketed paracetamol is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor associated with the clinical development program for this pain medicine.

What phase is marketed paracetamol in?

Marketed paracetamol has been studied in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study enrolled 30 participants and was conducted in the United States.

What clinical trials is marketed paracetamol in?

Marketed paracetamol has been evaluated in one clinical trial, NCT01592227, titled A Study to Compare Two Paracetamol Formulations. That Phase 1 trial is completed, enrolled 30 participants, was active controlled, and included healthy volunteers aged 18 years and older in the United States.

How was the marketed paracetamol Phase 1 trial designed?

The Phase 1 trial NCT01592227 compared two paracetamol formulations in pain. It was randomized and active controlled, enrolled 30 participants, and was not double blind. It included healthy volunteers of all sexes aged 18 years and older and was conducted in the United States.