Last updated: 11/04/2018 04:22:59

A study to compare two paracetamol formulations.

GSK study ID
A6480791
See study documents
Clinicaltrials.gov ID
NCT01592227
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 pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.
Trial description: A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: baseline to 10 hours post dose

Secondary outcomes:

Speed of absorption in fasted and semi-fed states

Timeframe: baseline to 10 hours post dose

Interventions:
  • Drug: Marketed paracetamol
  • Drug: Experimental paracetamol formulation
    • Enrollment:
    30
    Primary completion date:
    2009-31-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pain
    Product
    paracetamol
    Collaborators
    Not applicable
    Study date(s)
    December 2009 to December 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

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

    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
    2009-31-12
    Actual study completion date
    2009-31-12

    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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