Last updated: 11/04/2018 11:05:53

Nicotine Lozenge Bioequivalence Study

GSK study ID
S6491365
See study documents
Clinicaltrials.gov ID
NCT01536704
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 Single Dose Bioequivalence Study of 2 different doses of Mini Cherry Nicotine Lozenges
Trial description: To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.
Primary purpose:
Screening
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Area under the plasma concentration versus time curve from time zero to time t [AUC(0-t)]

Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Maximum observed plasma concentration [Cmaximum (max)]

Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Secondary outcomes:

AUC [0-infinity (inf)]

Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Time to reach maximum plasma nicotine concentration (Tmax)

Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Apparent elimination half-life of nicotine T(1/2)

Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Elimination rate constant for plasma nicotine: K (el)

Timeframe: Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours

Interventions:
  • Drug: Nicotine (2 mg)
  • Drug: Nicotine (4 mg)
    • Enrollment:
    50
    Primary completion date:
    2011-31-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Smoking Cessation
    Product
    nicotine
    Collaborators
    Not applicable
    Study date(s)
    July 2011 to August 2011
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    19 - 55 years
    Accepts healthy volunteers
    Yes
    • Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.
    • Body Mass Index within the range 19-27 kilograms/meters^2
    • Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.
    • Body Mass Index within the range 19-27 kilograms/meters^2
    Exclusion criteria:
    • Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Celerion NEBRASKA
    Lincoln, NE, United States, 68502
    Status
    Will Be Recruiting
    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
    2011-31-08
    Actual study completion date
    2011-31-08

    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website