Last updated: 11/04/2018 04:18:57

A pharmacokinetic study of an experimental paracetamol formulation

GSK study ID
A2260665
See study documents
Clinicaltrials.gov ID
NCT01476176
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A pivotal pharmacokinetic study investigating the extent of absorptions of paracetamol and caffeine for two different paracetomol formulations containing caffeine
Trial description: This PK study is designed to show bioequivalence between the study treatments.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence

Timeframe: 10 hours

Secondary outcomes:

PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)

Timeframe: 10 hours

Interventions:
  • Drug: Experimental paracetamol
  • Drug: Paracetamol marketed formulation
    • Enrollment:
    30
    Primary completion date:
    2009-31-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Headache, Tension-Type
    Product
    paracetamol
    Collaborators
    Not applicable
    Study date(s)
    July 2009 to August 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Healthy volunteer
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy volunteer

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    MDS Pharma Services ARIZONA
    Phoenix, AZ, United States, 85044
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2009-31-08
    Actual study completion date
    2009-31-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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