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A Pharmacokinetic Study of an Experimental Paracetamol Formulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476176
First Posted: November 22, 2011
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
November 22, 2011
November 24, 2014
July 2009
August 2009   (Final data collection date for primary outcome measure)
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence [ Time Frame: 10 hours ]
Same as current
Complete list of historical versions of study NCT01476176 on ClinicalTrials.gov Archive Site
PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax) [ Time Frame: 10 hours ]
Same as current
Not Provided
Not Provided
 
A Pharmacokinetic Study of an Experimental Paracetamol Formulation
A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine
This PK study is designed to show bioequivalence between the study treatments.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Headache, Tension-Type
  • Drug: Experimental paracetamol
    experimental paracetamol with caffeine
  • Drug: Paracetamol marketed formulation
    marketed formulation containing caffeine
  • Experimental: Experimental paracetamol formulation
    experimental formulation
    Intervention: Drug: Experimental paracetamol
  • Active Comparator: paracetamol marketed formulation
    Paracetamol marketed formulation
    Intervention: Drug: Paracetamol marketed 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
August 2009
August 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

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
 
 
NCT01476176
A2260665
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