Conditions: Tobacco Dependence
Keywords: Smoking Cessation Nicotine pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 45
Healthy volunteers: no

Brief summary:
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.

Detailed description:
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Arms:
arm 1: One oral administration of 1 mg nicotine arm 2: Two oral administrations of 1 mg nicotine arm 3: Four oral administrations of 1 mg nicotine arm 4: One 4 mg marketed nicotine lozenge arm 5: One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes

Interventions: intervention 1: Oral Nicotine intervention 2: NiQuitinTM Nicotine Lozenge intervention 3: Nicorette® Nicotine Gum
Intervention descriptions: intervention 1: A new l mg oral nicotine product intervention 2: A marketed 4 mg Nicotine lozenge intervention 3: A marketed 4 mg Nicotine Gum

Protocol document: