Tobacco Dependence
Conditions
Keywords
Smoking Cessation, Nicotine pharmacokinetics
Brief summary
Bioequivalence between oral nicotine replacement products and Nicorette® gum.
Detailed description
This study compares a new oral Nicotine Replacement Therapy (NRT) product containing 2 and 4 mg nicotine with Nicorette® gum 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 10 hours after start of administration. Single doses of each treatment are given once in the morning during four separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 88 healthy smokers between 18-50 years, who have been smoking at least 10 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.
Interventions
DRUGNicotine
Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg
DRUGNicorette® (Nicotine Gum)
Single-dose of marketed nicotine gum 2 mg or 4 mg
Sponsors
McNeil AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Healthy smokers, 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 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 (AUCinf) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | during 10 hours after start of product administration | The time of occurrence of Cmax (tmax) following product administration |
| λz | during 10 hours after start of product administration | The terminal nicotine elimination rate constant (λz) |
| Residual Nicotine | After 30 minutes of chewing | The amount of nicotine released from Nicorette® gum 2 and 4 mg during 30 minutes' chewing. |
| Dissolution Time | From product administration until completely dissolved | Actual time required for oral dissolution of new NRT products following product administration |
Countries
Sweden
Outcome results
None listed