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Paracetamol fast dissolution

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 Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

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 being developed by GSK plc for use in healthy subjects. It is a paracetamol formulation designed for fast dissolution. The drug is currently in Phase 1 clinical development, meaning it is still being studied and is not yet approved for any use.

What is Paracetamol fast dissolution used for?

Paracetamol fast dissolution is being studied for use in healthy subjects. It is intended as a paracetamol formulation, which is commonly used for pain relief and fever reduction. However, the specific indication for this fast dissolution version has not been established beyond its testing in healthy volunteers.

Who makes Paracetamol fast dissolution?

Paracetamol fast dissolution is developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting clinical research on this investigational paracetamol formulation.

What phase is Paracetamol fast dissolution in?

Paracetamol fast dissolution is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a pharmacokinetic study. The drug remains investigational and has not received regulatory approval.

What clinical trials is Paracetamol fast dissolution in?

Paracetamol fast dissolution has one completed clinical trial, NCT01476215, titled "A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions." This Phase 1 study enrolled 18 healthy male subjects in the United States and was active-controlled.

Is Paracetamol fast dissolution the same as paracetamol?

Paracetamol fast dissolution is a formulation of paracetamol, the common pain reliever and fever reducer. It is designed to dissolve quickly, which may affect how rapidly it is absorbed. However, it is an experimental formulation and is not the same as standard marketed paracetamol products.