Last reviewed · How we verify
A Single Dose Bioequivalence Study of 2mg and 4mg Nicotine Lozenges
Open label, single dose, four-way crossover in healthy smokers. Each subject will be treated with a single dose or four study treatments in a randomized sequence.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 32 |
| Start date | 2008-02 |
| Completion | 2008-03 |
Conditions
- Healthy Volunteer Smokers
Interventions
- 4 mg nicotine lozenge
- 2 mg nicotine lozenge
- 2 mg nicotine prototype
- 4 mg nicotine prototype
Primary outcomes
- To compare the 2mg prototype lozenge to the 2mg standard lozenge in terms of AUC0-infinity, tmax, t½, and Kel, and likewise 4mg prototype lozenge to 4mg standard lozenge. — 12 hours