Tobacco Dependence
Conditions
Keywords
Smoking Cessation, Nicotine pharmacokinetics
Brief summary
Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.
Detailed description
Forty-four (44) healthy male or female subjects will be included. Single doses of an experimental Nicotine medicated chewing gum 6 mg and Nicorette® Freshfruit gum 4 mg and 2 mg and NiQuitin™ Mint lozenge 4 mg will be administered in a standardized mode, on four separate treatment visits. Periods without nicotine replacement therapy, each lasting for at least 36 hours, will separate the treatment visits. The subjects will abstain from smoking from 8 pm the evening before each treatment visit and until the end of each visit. Blood for pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60 minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration. Subjects will be monitored to capture any adverse events that may occur.
Interventions
DRUGNicotine Medicated Gum
Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes
Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes
Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes
Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved
Sponsors
McNeil AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kilograms per square meter and a total body weight of at least 55.0 kilograms. * 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 Observed Plasma Concentration (Cmax) | 12 hours post-dose | Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL) |
| Area Under the Curve (AUC)(0-t) | 12 hours post-dose | AUC(0-t), which is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \* nanograms (ng) per milliliter (mL). |
| AUC (0-∞) | 12 hours post-dose | AUC (0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC(10 min) | 10 minutes post-dose | AUC(10 min) which is the area under the plasma concentration verses time curve from start of drug administration until 10 minutes |
Countries
Sweden
Outcome results
None listed