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Marketed paracetamol

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 Trials2
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Marketed paracetamol · 3 trials · 2 indications

Phase 1 3
NCT01540721Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® ExtendHealthy Subjects
COMPLETED28 Analytics
NCT01540734Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®Healthy Subjects
COMPLETED28 Analytics
NCT01592227A Study to Compare Two Paracetamol Formulations.Pain
COMPLETED30 Analytics
PHASE1COMPLETED
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol® Extend
Healthy Subjects
NCT0154072128
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PHASE1COMPLETED
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®
Healthy Subjects
NCT0154073428
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PHASE1COMPLETED
A Study to Compare Two Paracetamol Formulations.
Pain
NCT0159222730
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Study Endpoints

Primary Endpoints

Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state
baseline to 12 hours
Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax
baseline to 12 hours
To compare bioavailability as measured by Area under the Curve in both fed and fasted states
Visit 1 through Visit 3 (Day 13)
To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax
Visit 1 through Visit 3 (Day 13)
Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states
baseline to 10 hours post dose

Secondary Endpoints

To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)
baseline to 12 hours
To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax)
Visit 1 through Visit 3 (Day 13)
Speed of absorption in fasted and semi-fed states
baseline to 10 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Experimental paracetamol formulationEXPERIMENTALExperimental formulation
Marketed paracetamolACTIVE_COMPARATORMarketed formulation

Interventions

NameTypeDescription
Marketed paracetamolDRUGmarketed formulation
Experimental paracetamol formulationDRUGExperimental formulation
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination Exclusion Criteria: * Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs ...

Countries:United States
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Frequently asked questions about Marketed paracetamol

What is marketed paracetamol used for?

Marketed paracetamol is used for pain and is studied in healthy subjects. It is a small molecule being developed by GSK plc. The drug is in Phase 1 clinical development, with completed trials evaluating its absorption and comparing different formulations.

Who makes marketed paracetamol?

Marketed paracetamol is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting Phase 1 clinical trials to study the drug's pharmacokinetics and compare formulations.

What phase is marketed paracetamol in?

Marketed paracetamol is in Phase 1 clinical development. It is an investigational drug, not yet approved, with two completed Phase 1 trials. The trials are active-controlled and randomized, but not double-blinded, and have enrolled a total of 56 participants.

What clinical trials is marketed paracetamol in?

Marketed paracetamol has two completed Phase 1 trials: NCT01540721 and NCT01540734, both studying paracetamol absorption in healthy subjects in the United States. A third trial, NCT01592227, compares two paracetamol formulations in pain. All trials are completed with enrollment ranging from 28 to 30 participants.

Is marketed paracetamol the same as Panadol?

Marketed paracetamol is being compared with Panadol Extend and Panadol in clinical trials. The trials NCT01540721 and NCT01540734 investigate the extent of paracetamol absorption from a new formulation compared with these Panadol products, indicating they are different formulations of the same active ingredient.