Tobacco Dependence
Conditions
Keywords
Smoking Cessation, Nicotine pharmacokinetics
Brief summary
This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.
Detailed description
This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.
Interventions
DRUGNicotine
Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
DRUGNicotine Gum
Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 |
|---|---|---|
| Maximum Concentration | Baseline to 10 hours post-dose | The maximum observed nicotine concentration in plasma (Cmax) |
| Area under the Curve | 10 hours post-dose | 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 to Maximum Concentration | 10 hours post-dose | Time to Maximum Concentration (Tmax) |
| Residual Nicotine | 30 minutes | The amount of residual nicotine in the product after being chewed. |
| Dissolution Time | 10 hours post-dose | Actual time required for oral dissolution of new NRT products following product administration |
Countries
Sweden
Outcome results
None listed