Pharmacokinetic Study of 4 mg Nicotine Lozenge.

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.

Timeline

Start

2012-06

Primary completion

2012-08

Completion

2012-08

Drugs

Indications

No indication recorded.