Nicotine Lozenge Bioequivalence Study
- Registration Number
- NCT01536704
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Reference nicotine lozenge (2 mg) Nicotine (2 mg) 2 mg reference nicotine lozenge to be chewed. Test nicotine lozenge (2 mg) Nicotine (2 mg) 2 mg test nicotine lozenge to be chewed. Test nicotine lozenge (4 mg) Nicotine (4 mg) 4 mg test nicotine lozenge to be chewed. Reference nicotine lozenge (4 mg) Nicotine (4 mg) 4 mg reference nicotine lozenge to be chewed.
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] 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 AUC(0-t) was evaluated using the trapezoid rule.
Maximum Observed Plasma Concentration [Cmaximum (Max)] 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 Cmax was depicted from plasma concentration of nicotine.
- Secondary Outcome Measures
Name Time Method AUC [0-infinity (Inf)] 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 AUC (0-inf) was evaluated using the trapezoid rule.
Time to Reach Maximum Plasma Nicotine Concentration (Tmax) 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 Tmax was time at which Cmax of nicotine was reached.
Apparent Elimination Half-life of Nicotine T(1/2) 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 T(1/2) was calculated using plasma time-concentration values.
Elimination Rate Constant for Plasma Nicotine: K (el) 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 Kel was calculated with the help of plasma time concentration values.
Trial Locations
- Locations (1)
Celerion NEBRASKA
🇺🇸Lincoln, Nebraska, United States