Phase 1
N=50
Nicotine Lozenge Bioequivalence Study
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01536704 ↗Enrolled (actual)
50
Serious AEs
0.5%
Results posted
Apr 2013
Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] — 18.84; 20.71; 34.71; 33.68 nanogram (ng).hour (hr)/millilitre (mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nicotine (2 mg) (Drug); Nicotine (4 mg) (Drug)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] |
18.84; 20.71; 34.71; 33.68 | — |
| PRIMARY Maximum Observed Plasma Concentration [Cmaximum (Max)] |
5.67; 6.35; 9.37; 9.72 | — |
| SECONDARY AUC [0-infinity (Inf)] |
21.03; 22.66; 37.48; 36.08 | — |
| SECONDARY Time to Reach Maximum Plasma Nicotine Concentration (Tmax) |
0.83; 0.67; 0.83; 0.83 | 0.1491 |
| SECONDARY Apparent Elimination Half-life of Nicotine T(1/2) |
3.39; 3.41; 3.19; 3.13 | 0.5619 |
| SECONDARY Elimination Rate Constant for Plasma Nicotine: K (el) |
0.20; 0.20; 0.22; 0.22 | 0.5113 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01536704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.