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Experimental paracetamol

Phase 1

Headache, Tension-Type | Small molecule | Pain |GSK plc|Last Updated: Nov 24, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Experimental paracetamol · 1 trial · 1 indication

Phase 1 1
NCT01476176A Pharmacokinetic Study of an Experimental Paracetamol FormulationHeadache, Tension-Type
COMPLETED30 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study of an Experimental Paracetamol Formulation
Headache, Tension-TypeUnlock trial analytics

Study Endpoints

Primary Endpoints

PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence
10 hours

Secondary Endpoints

PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)
10 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Experimental paracetamol formulationEXPERIMENTALexperimental formulation
paracetamol marketed formulationACTIVE_COMPARATORParacetamol marketed formulation

Interventions

NameTypeDescription
Experimental paracetamolDRUGexperimental paracetamol with caffeine
Paracetamol marketed formulationDRUGmarketed formulation containing caffeine
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteer Exclusion Criteria: \-

Countries:United States
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Frequently asked questions about Experimental paracetamol

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.