Last updated: 11/04/2018 04:20:43

Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption from a new formulation of Paracetamol Compared with Panadol® Extend

GSK study ID
A2750605
See study documents
Clinicaltrials.gov ID
NCT01540721
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 PK study investigating the extent of paracetamol absorption from two different sustained released paracetamol formulations
Trial description: This study will evaluate the pharmacokinetic profiles of experimental formulations of paracetamol.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Bioavailability as measured by Area Under the Curve (AUC) in both fasted and fed state

Timeframe: baseline to 12 hours

Effect of food on the extent and rate of paracetamol absorption as measured by AUC and Cmax

Timeframe: baseline to 12 hours

Secondary outcomes:

To assess descriptive pharmaokinetic characteristics (Tmax, T1/2, Cmax, AUC)

Timeframe: baseline to 12 hours

Interventions:
  • Drug: Marketed paracetamol
  • Drug: Experimental paracetamol formulation
    • Enrollment:
    28
    Primary completion date:
    2010-05-01
    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)
    December 2009 to January 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
    • Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Good health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination
    Exclusion criteria:
    • Current (within 14 days of screening) or regular use of any prescription, over the counter (OTC) drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism, excluding prescription birth control, if applicable.

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

    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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