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Paracetamol fast dissolution

Phase 1

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

Paracetamol fast dissolution target and mechanism

ModalitySmall molecule

Also known as Paracetamol fast dissolution suspension

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Paracetamol fast dissolution clinical trials

Paracetamol fast dissolution · 1 trial · 1 indication

Phase 1 1
NCT01476215A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric SuspensionsHealthy Subjects
COMPLETED18 Analytics
PHASE1COMPLETED
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to plasma level above therapeutic level
baseline to 8 hours

Secondary Endpoints

General PK parameters (e.g. AUC, Tmax, Cmax)
baseline to 8 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Fast dissolution suspensionEXPERIMENTAL -
Medium dissolution suspensionEXPERIMENTAL -
Slow dissolution suspensionEXPERIMENTAL -
Marketed suspensionACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Paracetamol fast dissolution suspensionDRUG -
Paracetamol medium dissolution suspensionDRUG -
Paracetamol slow dissolution suspensionDRUG -
ParacetamolDRUG -
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Eligibility Criteria

Age Range19 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteer * Body Mass Index between 19.0 - 28.0 (kg/m2) inclusive

Countries:United States
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Frequently asked questions about Paracetamol fast dissolution

What is Paracetamol fast dissolution?

Paracetamol fast dissolution is an investigational small molecule formulation of paracetamol developed by GSK plc. It is designed as a fast-dissolving suspension, and the only listed trial studied experimental sustained release pediatric suspensions in healthy adult male subjects. No approved indication has been disclosed for this formulation.

Who is developing Paracetamol fast dissolution?

Paracetamol fast dissolution is being developed by GSK plc, which trades under the ticker GSK. GSK sponsored the pharmacokinetic study of this formulation. The asset remains in early clinical development under GSK's pipeline.

What phase is Paracetamol fast dissolution in?

Paracetamol fast dissolution is in Phase 1 development. One Phase 1 pharmacokinetic trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.

What clinical trials is Paracetamol fast dissolution in?

Paracetamol fast dissolution has been studied in one completed Phase 1 trial, NCT01476215, titled a pharmacokinetic study investigating the rate and extent of paracetamol absorption of three experimental sustained release pediatric suspensions. The trial enrolled 18 healthy male subjects in the United States and was active-controlled and randomized.

Is Paracetamol fast dissolution the same as Paracetamol fast dissolution suspension?

Yes, Paracetamol fast dissolution suspension is an alternative name for Paracetamol fast dissolution. Both names refer to the same GSK plc investigational formulation studied in the completed Phase 1 pharmacokinetic trial NCT01476215.