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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2011-31-08
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
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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
Completed
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
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