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A Study to Compare Two Paracetamol Formulations.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01592227
First Posted: May 7, 2012
Last Update Posted: November 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
November 17, 2011
May 7, 2012
November 24, 2014
December 2009
December 2009   (Final data collection date for primary outcome measure)
Bioequivalence as measured by AUC and Cmax in fasted and semi-fed states [ Time Frame: baseline to 10 hours post dose ]
Same as current
Complete list of historical versions of study NCT01592227 on ClinicalTrials.gov Archive Site
Speed of absorption in fasted and semi-fed states [ Time Frame: baseline to 10 hours post dose ]
Same as current
Not Provided
Not Provided
 
A Study to Compare Two Paracetamol Formulations.
A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol Formulations.
A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Pain
  • Drug: Marketed paracetamol
    Marketed paracetamol
  • Drug: Experimental paracetamol formulation
    Experimental paracetamol formulation
  • Active Comparator: Marketed paracetamol
    Marketed paracetamol
    Intervention: Drug: Marketed paracetamol
  • Experimental: Experimental paracetamol formulation
    Experimental formulations
    Intervention: Drug: Experimental paracetamol formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01592227
A6480791
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP