Conditions: Smoking Cessation
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 40
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: 4mg nicotine lozenge administered orally as a single dose treatment per subject arm 2: 4mg nicotine lozenge administered orally as a single dose treatment per subject arm 3: 4mg nicotine lozenge administered orally as a single dose treatment per subject arm 4: 4mg nicotine lozenge (internationally marketed) to be administered orally as a single dose treatment per subject.

Interventions: intervention 1: nicotine
Intervention descriptions: intervention 1: 4 mg nicotine lozenge experimental

Protocol document: