Conditions: Tobacco Dependence
Keywords: Smoking Cessation Nicotine
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 84
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

Detailed description:
The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Arms:
arm 1: An experimental 2 mg nicotine product coded "STD" arm 2: An experimental 2 mg nicotine product coded "STE" arm 3: A comparative 2 mg marketed nicotine product called Nicorette Microtab

Interventions: intervention 1: Code STD intervention 2: Code STE intervention 3: Nicorette Microtab
Intervention descriptions: intervention 1: 2 mg Single-dose of experimental nicotine product coded "STD" intervention 2: 2 mg Single-dose of experimental nicotine product coded "STE" intervention 3: A comparative 2 mg Single-dose of marketed tablet

Protocol document: