Tobacco Dependence
Conditions
Keywords
Smoking Cessation, Nicotine pharmacokinetics
Brief summary
This study examines the bioequivalence between an oral nicotine replacement product and Nicorette® gum.
Detailed description
The study is a single-dose, randomized, crossover study with 76 subjects (all subjects will receive all treatments). 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. Blood for pharmacokinetic analyses will be drawn before and at 5, 10, 15, 20, 30, 45, and 60 minutes, as well as at 1.5, 2, 4, 6, 8, and 10 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.
Interventions
DRUGNicotine
Single-dose of new NRT product
DRUGNicotine Gum
Single-dose of marketed nicotine gum
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
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 body mass index (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 10 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 10 hours after product administration | The time of occurrence of Cmax following product administration |
| Lamda z | Baseline and during 10 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