Tobacco Dependence
Conditions
Keywords
Smoking Cessation, Nicotine pharmacokinetics
Brief summary
Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.
Detailed description
The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects, study personnel, monitor, and analysts.
Interventions
DRUGNicotine
2 mg Single-dose
Sponsors
McNeil AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 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 |
|---|---|---|
| Pharmacokinetic measurements | Baseline and during 8 hours after product administration | Pharmacokinetic measurements including: * the maximum observed nicotine concentration in plasma (Cmax) * the area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt) * the area under the plasma concentration-vs.-time curve until infinity (AUC∞) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tmax | Baseline and during 8 hours after product administration | The time of occurrence of Cmax following product administration |
| Lamda z | Baseline and during 8 hours after product administration | The terminal nicotine elimination rate constant (λz) |
| Released amount of nicotine | After 30 minutes of chewing | The amount of nicotine released from gums during 30 minutes' chewing |
Countries
Sweden
Outcome results
None listed