Last updated: 11/04/2018 10:25:35

Pharmacokinetic study of 4 mg nicotine lozenge.

GSK study ID
RH01333
See study documents
Clinicaltrials.gov ID
NCT01669122
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 Randomized, Cross-Over, Single Dose Pharmacokinetic Study of 4mg Nicotine Lozenges.
Trial description: This is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12 hours post dose in each treatment session and plasma samples analyzed for nicotine levels.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Area under the curve from time 0 to t, AUC (0-t)

Timeframe: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Maximum plasma concentration (Cmax)

Timeframe: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Secondary outcomes:

AUC(0-inf)

Timeframe: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Time to maximum plasma concentration (Tmax)

Timeframe: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Rate of elimination (Kel)

Timeframe: Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Plasma half life (t1/2)

Timeframe: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Interventions:
  • Drug: nicotine
    • Enrollment:
    40
    Primary completion date:
    2012-31-08
    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)
    June 2012 to August 2012
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening.
    • inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing
    Inclusion and exclusion criteria
    Inclusion criteria:
    • smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening.
    Exclusion criteria:
    • inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Lambda Therapeutic Research Ltd
    Ahmedabad, Gujarat, India, 380 061
    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
    2012-31-08
    Actual study completion date
    2012-31-08

    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
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