Tobacco use Not Applicable Tobacco use
Conditions
Interventions
Test products:
1. ZYN® Smooth containing 6 mg nicotine per portion
2. ZYN® Smooth containing 8 mg nicotine per portion
3. ZYN® Wintergreen containing 6
Sponsors
Swedish Match Europe Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Snus user who have used snus for =1 year, with a minimum weekly consumption of two or more snus cans (brands with nicotine content =1%) 2. Willing and able to give written informed consent for participation in the study 3. Healthy 4. Aged 19 years or older 5. Willing and able to comply with study procedures
Exclusion criteria
Exclusion criteria: 1. Smoker, defined as "smoking during the last 24 hours" according to self-report and CO in exhaled air >10 ppm at clinical visits 2. A history or presence of diagnosed hypertension or any cardiovascular disease 3. Surgery within 6 months of the screening visit that, in the opinion of the investigator, could negatively impact on the subject’s participation in the clinical study 4. Any surgical or medical condition, which, in the judgement of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product 5. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study 6. Breast feeding, pregnancy or planning to get pregnant during the study 7. Female use of systemic contraceptives (such as oral contraceptives, implants, injectable steroids, vaginal ring, transdermal patch) 8. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) 9. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IP 10. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse 11. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening 12. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCinf (based on plasma concentrations of nicotine after administration of a single dose of ZYN® Smooth containing 6 mg of nicotine, to that of two doses of General PSWL Swedish snus pouches), calculated based on measurement of nicotine in blood samples with a liquid chromatography-mass spectrometry (LC-MS/MS) analytical method at the completion of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The following pharmacokinetic parameters of the non-tobacco-based nicotine ZYN® Smooth pouches, General PSWL Swedish snus pouches and Longhorn American moist snuff pouches, calculated based on measurement of nicotine in blood samples with a liquid chromatography-mass spectometry (LC-MS/MS) analytical method at the completion of the study: 1.1. Tmax 1.2. Cmax 1.3. AUCinf 1.4. AUC0-t 1.5. Terminal half-life 2. Nicotine plasma concentrations for the ZYN® Wintergreen and Longhorn Wintergreen treatments compared to the corresponding non-wintergreen containing product, respectively, calculated based on measurement of nicotine in blood samples with a LC-MS/MS analytical method at the completion of the study 3. Nicotine plasma concentrations for the upper lip and lower lip placement of the non-tobacco-based nicotine pouch ZYN® Smooth, calculated based on measurement of nicotine in blood samples with a LC-MS/MS analytical method at the completion of the study 4. In vivo extracted amount of nicotine from all products, measured by subtracting the residual amount after use from the mean of 10 unused portions at completion of the study 5. Pairwise analysis of in-vitro extracted nicotine and extraction grade, measured by statistical evaluation of data at completion of the study 6. Plasma levels of Methyl salicylate for the treatments with pouches containing Wintergreen flavour, calculated based on measurement of nicotine in blood samples with a LC-MS/MS analytical method at the completion of the study 7. Adverse events measured by patient interviews during each visit | — |
Countries
Sweden
Outcome results
None listed