Last updated: 11/04/2018 04:22:01

A study to compare two paracetamol tablets

GSK study ID
A4040689
Clinicaltrials.gov ID
NCT01381640
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A single dose pharmacoscintigraphic study investigating the differences in gastrointestinal behavior and paracetamol absorption between sustained release formula and standard release formula
Trial description: This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Time of onset and completion of disintegration based on release of radiolabeled markers in a fed condition

Timeframe: Baseline to 12 hours post dosing

Secondary outcomes:

To assess the gastrointestinal transit by qualitative scintigraphic analysis

Timeframe: Baseline to 12 hours post dosing

Interventions:
  • Drug: Marketed paracetamol
  • Drug: Experimental paracetamol formulation
    • Enrollment:
    0
    Primary completion date:
    2010-30-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects
    Product
    paracetamol
    Collaborators
    Not applicable
    Study date(s)
    April 2010 to April 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Healthy male subjects who are in good general health
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Healthy male subjects who are in good general health
    • Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    BIO-IMAGES Research Ltd.
    Glasgow, Scotland, United Kingdom, G63 0BX
    Status
    Will Be Recruiting
    Contact us
    Location
    BIO-IMAGES
    Glasgow, Scotland, United Kingdom, G63 0BX
    Status
    Will Be Recruiting
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    2010-30-04
    Actual study completion date
    2010-30-04

    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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