Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Pharmacokinetic Study of an Experimental Paracetamol Formulation

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: November 17, 2011
Last updated: June 19, 2014
Last verified: February 2014

November 17, 2011
June 19, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01476176 on Archive Site
PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax) [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
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
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Identifier (NCT Number) in Medline.
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:


18 Years to 55 Years
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
February 2014

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