CClinicalTrials.gg
CompletedNCT01592227Updated Nov 24, 2014

A Study to Compare Two Paracetamol Formulations.

A Phase 1 interventional study of Marketed paracetamol and Experimental paracetamol formulation in Pain, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-24.

Sponsored by GlaxoSmithKline · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.

02

Conditions studied

  • Pain

Keywords

  • healthy volunteer
  • pharmacokinetics
  • paracetamol
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Marketed paracetamol

    Marketed paracetamol

    Drug: Marketed paracetamol

  • Experimental
    Experimental paracetamol formulation

    Experimental formulations

    Drug: Experimental paracetamol formulation

Interventions

  • DrugMarketed paracetamol

    Marketed paracetamol

  • DrugExperimental paracetamol formulation

    Experimental paracetamol formulation

06

What researchers measure

Primary outcomes

  1. Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states

    Time frame: baseline to 10 hours post dose

Secondary outcomes

  1. Speed of absorption in fasted and semi-fed states

    Time frame: baseline to 10 hours post dose

07

Study locations

1 site
  • MDS Pharma Services ARIZONA
    Phoenix, Arizona 85044, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01592227
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
May 7, 2012
Start date
Dec 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Nov 24, 2014

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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