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Experimental paracetamol formulation

Phase 1

Healthy Subjects | Small molecule | Other |GSK plc|Last Updated: Nov 24, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Experimental paracetamol formulation · 1 trial · 1 indication

Phase 1 1
NCT01476189A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol FormulationsHealthy Subjects
COMPLETED28 Analytics
PHASE1COMPLETED
A Study to Compare to the Pharmacokinetic Profile of Two Paracetamol Formulations
Healthy SubjectsUnlock trial analytics

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 to 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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Frequently asked questions about Experimental paracetamol formulation

What is Experimental paracetamol used for?

Experimental paracetamol is an investigational small molecule being studied for the treatment of tension-type headache and in healthy subjects. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes Experimental paracetamol?

Experimental paracetamol is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK.

What phase is Experimental paracetamol in?

Experimental paracetamol is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and pharmacokinetics.

What clinical trials is Experimental paracetamol in?

Experimental paracetamol has been studied in two completed Phase 1 clinical trials: NCT01476176, a pharmacokinetic study in patients with tension-type headache, and NCT01476189, a study comparing the pharmacokinetic profile of two paracetamol formulations in healthy subjects.

Is Experimental paracetamol the same as paracetamol?

Experimental paracetamol is an investigational formulation of paracetamol, also known as acetaminophen. It is being studied to evaluate its pharmacokinetic profile compared to other paracetamol formulations.