Tobacco Dependence
Conditions
Keywords
Smoking Cessation, Nicotine pharmacokinetics
Brief summary
Comparative pharmacokinetic study of new oral nicotine replacement therapy products.
Detailed description
This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.
Interventions
DRUGExperimental Nicotine Replacement Therapy (NRT) 2 mg
2 mg Single-dose of new NRT product (NSL2L)
DRUGExperimental Nicotine Replacement Therapy (NRT)
4 mg Single-dose of new NRT product
DRUGMarketed Nicotine Lozenge
2 mg Single-dose of marketed lozenge
Sponsors
McNeil AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2. * Female participants of child-bearing potential are required to use a medically acceptable means of birth control. * A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion criteria
* Pregnancy, lactation or intended pregnancy. * Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration | during 12 hours after product administration | The maximum observed nicotine concentration in plasma (Cmax) |
| Area under the Curve | after 12 hours | The area under the plasma concentration-vs-time curve until the last measurable concentration (AUCt) and the area under the plasma concentration-vs.-time curve until infinity (AUC∞) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Maximum Concentration | during 12 hours after start of product administration | The time of occurrence of maximum concentration (Tmax) |
| Terminal Elimination Rate Constant | during 12 hours after start of product administration | The terminal nicotine elimination rate constant (λz) |
| Oral Dissolution Time | from administration until completely dissolved | Actual time required for oral dissolution |
Countries
Sweden
Outcome results
None listed