Last updated: 11/04/2018 12:29:32

An Open-Label, Single-Dose and Multi-Dose Pharmacokinetic Study of 2mg and 4mg Nicotine Lozenge in Chinese Smokers

GSK study ID
S-RHS00289
See study documents
Clinicaltrials.gov ID
Not applicable
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: An Open-Label, Single-Dose and Multi-Dose Pharmacokinetic Study of 2mg and 4mg Nicotine Lozenge in Chinese Smokers
Trial description: Nicotine replacement therapy has been demonstrated to facilitate smoking cessation. This study aimed to evaluate the pharmacokinetic parameters of 2mg and 4mg Nicotine Lozenge following single-dose and multiple doses administration in Chinese population.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Area under the curve from 0 to t [AUC[0-t)] following single dose

Timeframe: Blood samples were collected at one time point immediately before dosing and at 12 time points post dosing ( 15 mins, 30 mins, 45 mins, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours).

Maximum plasma concentration (Cmax) following single dose

Timeframe: Blood samples were collected at one time point immediately before dosing and at 12 time points post dosing ( 15 mins, 30 mins, 45 mins, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours).

Steady-state plasma concentration (Css, max) following multiple-dose session

Timeframe: Blood samples were collected at one time point immediately before the first dose (0 hour), immediately before the 7th, 8th and 9th dose and at these times following the 9th dose: 10minutes (min), 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min.

AUC(0-tau) following multiple-dose session

Timeframe: Blood samples were collected at one time point immediately before the first dose (0 hour), immediately before the 7th, 8th and 9th dose and at these times following the 9th dose: 10minutes (min), 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min.

Secondary outcomes:

Tmax, ss following multiple dose session

Timeframe: Blood samples were collected at one time point immediately before the first dose (0 hour), immediately before the 7th, 8th and 9th dose and at these times following the 9th dose: 10minutes (min), 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min.

AUC(0-inf) following single dose session

Timeframe: Blood samples were collected at one time point immediately before dosing and at 12 time points post dosing ( 15 mins, 30 mins, 45 mins, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours).

Tmax following single dose session

Timeframe: Blood samples were collected at one time point immediately before dosing and at 12 time points post dosing ( 15 mins, 30 mins, 45 mins, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours).

Degree of fluctuation

Timeframe: Blood samples were collected at one time point immediately before the first dose (0 hour), immediately before the 7th, 8th and 9th dose and at these times following the 9th dose: 10minutes (min), 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min.

Css, av following multiple dose session

Timeframe: Blood samples were collected at one time point immediately before the first dose (0 hour), immediately before the 7th, 8th and 9th dose and at these times following the 9th dose: 10minutes (min), 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min.

Css,min following multiple dose session

Timeframe: Blood samples were collected at one time point immediately before the first dose (0 hour), immediately before the 7th, 8th and 9th dose and at these times following the 9th dose: 10minutes (min), 20min, 30min, 40min, 50min, 60min, 70min, 80min, 90min.

Interventions:
  • Drug: Nicotine
    • Enrollment:
    38
    Primary completion date:
    Not applicable
    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)
    October 2009 to December 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    yes
    • Participant with a body mass index within the range 19-27 kg/m2.
    • Participant routinely smoked his or her first cigarette within 30 minutes upon awakening was in the 4mg treatment group; after 30 minutes was in the 2mg treatment group.
    • Participant with a disease or condition that may interfere with the oral absorption of the study drugs .
    • Participant who used tobacco products other than cigarettes within 14 days of screening visit.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participant with a body mass index within the range 19-27 kg/m2.
    • Participant routinely smoked his or her first cigarette within 30 minutes upon awakening was in the 4mg treatment group; after 30 minutes was in the 2mg treatment group.
    Exclusion criteria:
    • Participant with a disease or condition that may interfere with the oral absorption of the study drugs .
    • Participant who used tobacco products other than cigarettes within 14 days of screening visit.
    • Participant with known or suspected intolerance or hypersensitivity to any of the study materials or closely related compounds or any of their stated ingredients.
    • Participant with used any nicotine replacement therapy within 21 days prior to the first study session.

    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
    Not applicable
    Actual study completion date
    2009-26-12

    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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