Last updated: 11/04/2018 04:23:09

A study to investigate a new paracetamol formulation

GSK study ID
A6480804
See study documents
Clinicaltrials.gov ID
Not applicable
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 single dose pharmacoscintigraphic study investigating the differences in gastrointestinal behaviour and paracetamol absorption between two paracetamol formulations
Trial description: This study has been designed to compare a new paracetamol formulation with a marketed formulation.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

To determine tablet disintegration time

Timeframe: baseline to 30 minutes post dosing

Secondary outcomes:

Time to completion of tablet disintegration

Timeframe: baseline to 10 hours post dosing

To compare pharmacokinetic profiles of two paracetamol formulations

Timeframe: Up to 10 hours post dose

Time to assess detectable levels of drug absorption

Timeframe: baseline to 10 hours post dosing

Time to reach the minimal therapeutic level of paracetamol

Timeframe: baseline to 10 hours post dosing

To assess the frequency of adverse events

Timeframe: baseline to 10 hours post dosing

Interventions:
  • Drug: Marketed paracetamol
  • Drug: Experimental paracetamol formulation
    • Enrollment:
    35
    Primary completion date:
    2010-01-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects, Analgesia
    Product
    paracetamol
    Collaborators
    Not applicable
    Study date(s)
    March 2010 to May 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 65 Year
    Accepts healthy volunteers
    yes
    • Inclusion Criteria:
    • Healthy male subjects who are in good general health and who have not exceeded the limits of total radiation exposure allowed in any 12 month period.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Healthy male subjects who are in good general health and who have not exceeded the limits of total radiation exposure allowed in any 12 month period.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    2010-01-05
    Actual study completion date
    2010-01-05

    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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