Last updated: 11/04/2018 05:48:06

A comparison of solid and soluble forms of cold and influenza remedies

GSK study ID
C7591227
See study documents
Clinicaltrials.gov ID
NCT01332578
See results summary
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 comparison of solid and soluble forms of cold and influenza remedies
Trial description: The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. The study will also assess the gastrointestinal transit of two oral cold and influenza (‘flu’) formulations using gamma scintigraphy. It is postulated that paracetamol in solution, such as from cold and ‘flu’ hot remedies, provides a greater early exposure compared to standard paracetamol tablets. In addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Time to reach plasma paracetamol concentration of 0.25 μg/mL (microgram per milliliter)

Timeframe: Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

Secondary outcomes:

Area under the concentration/time curve from 0 to 30 minutes (min) (AUC 0-30 min)

Timeframe: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

AUC (0-60 min)

Timeframe: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

Maximum Plasma Concentration (Cmax)

Timeframe: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

Time to maximum plasma concentration (Tmax)

Timeframe: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

Time to onset of gastric emptying

Timeframe: Baseline to 10 hours

Time to completion of Gastric Emptying

Timeframe: Baseline to 10 hours

Time to onset and completion of disintegration of reference tablets

Timeframe: Baseline to 10 hours post dose

Interventions:
  • Drug: Paracetamol
  • Drug: Phenylephrine
  • Drug: Ascorbic Acid
    • Enrollment:
    25
    Primary completion date:
    2011-30-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza, Common cold
    Product
    paracetamol
    Collaborators
    Not applicable
    Study date(s)
    May 2011 to June 2011
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Healthy male volunteers
    • Body mass index between 18.0-29.9 kg/m^2
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male volunteers
    • Body mass index between 18.0-29.9 kg/m^2

    Trial location(s)

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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2011-30-06
    Actual study completion date
    2011-30-06

    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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