Last updated: 11/04/2018 04:17:58

Pharmacokinetic study to compare two formulations of paracetamol

GSK study ID
A1900832
See study documents
Clinicaltrials.gov ID
NCT01767428
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 to Evaluate the Rate and Extent of Absorption of Paracetamol from Two Formulations in an Indian Population.
Trial description: A pharmacokinetic study in healthy volunteers comparing two formulations of paracetamol fast release in fasted state.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

AUC (0-inf)

Timeframe: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.

Cmax

Timeframe: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.

AUC (0-t)

Timeframe: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.

Secondary outcomes:

Tmax

Timeframe: Blood samples drawn at 15 minutes pre-dose, then at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 minutes post dose and then at 2, 3, 4, 6, 8, 10, 12 hrs post dose.

Interventions:
  • Drug: Paracetamol
    • Enrollment:
    30
    Primary completion date:
    2010-30-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Fever, Headache Disorders, Pain
    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
    • Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study
    • BMI must be within the range 18.5 – 24.9 kg/m^2
    • Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure)
    • Participant with known or suspected intolerance or hypersensitivity to the study materials
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male volunteers aged 18-55yrs willing to give written informed consent for the study
    • BMI must be within the range 18.5 – 24.9 kg/m^2
    • Participant with a minimum weight of 50 kg
    Exclusion criteria:
    • Participant with current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure)
    • Participant with known or suspected intolerance or hypersensitivity to the study materials
    • Participant who are vegetarian
    • Participant smoking more than five cigarettes a day

    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
    2010-30-04
    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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