Tobacco Dependence
Conditions
Keywords
Smoking Cessation, Nicotine pharmacokinetics
Brief summary
Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.
Detailed description
Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each visit.
Interventions
DRUGNicotine
6 mg experimental Nicotine Replacement Therapy (NRT)
Sponsors
McNeil AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion. * BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg. * 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. * Willing and able to comply with all scheduled visits and study procedures
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. * Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration | within the last dosing interval (starting at 10.5-11 hours after first product administration) | Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL) |
| Average Concentration | within the last dosing interval (starting at 10.5-11 hours after first product administration) | Average Nicotine Plasma Concentration (Cav) within the last dosing interval |
| Area Under the Curve | within the last dosing interval (starting at 10.5-11 hours after first product administration) | Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swing | within the last dosing interval (starting at 10.5-11 hours after first product administration) | Swing in one dosing interval at steady state, calculated as (Cmax-Cmin)/ Cmin |
| Time of Maximum Concentration | During 12 hours post-dose | The time at which maximum concentration is reached (Tmax) |
| Nicotine Released | 30 minutes | The amount of nicotine released from the product during product administration |
| Minimum Observed Concentration | within the last dosing interval (starting at 10.5-11 hours after first product administration) | Minimum Observed Plasma Concentration (Cmin), which is the minimum concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL) |
| Peak-Trough Fluctuation | within the last dosing interval (starting at 10.5-11 hours after first product administration) | Percent of Peak-Trough Fluctuation in one dosing interval at steady state (PTF) |
Countries
Sweden
Outcome results
None listed