Last updated: 11/04/2018 04:21:32

A pharmacokinetic study investigating the rate and extent of paracetamol absorption of three experimental sustained release pediatric suspensions

GSK study ID
A3950669
See study documents
Clinicaltrials.gov ID
NCT01476215
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 paracetamol absorption of three experimental sustained release pediatric suspensions
Trial description: This proof of principle PK study will allow GSKCH to select the most favorable sustained release formulation among 3 prototypes to move to the next stage of drug development.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Time to plasma level above therapeutic level

Timeframe: baseline to 8 hours

Secondary outcomes:

General PK parameters (e.g. AUC, Tmax, Cmax)

Timeframe: baseline to 8 hours

Interventions:
  • Drug: Paracetamol fast dissolution suspension
  • Drug: Paracetamol medium dissolution suspension
  • Drug: Paracetamol slow dissolution suspension
  • Drug: Paracetamol
    • Enrollment:
    18
    Primary completion date:
    2009-30-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    November 2009 to November 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    19 - 50 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Healthy volunteer
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Healthy volunteer
    • Body Mass Index between 19.0
    • 28.0 (kg/m2) inclusive

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    MDS Pharma Services NEBRASKA
    Lincoln, NE, United States, 68501
    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
    2009-30-11
    Actual study completion date
    2009-30-11

    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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    Access to clinical trial data by researchers
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