Tobacco use Not Applicable
Conditions
Interventions
1. ZYN Smooth containing 3 mg nicotine per portion
2. ZYN Smooth containing 6 mg nicotine per portion
3. ZYN Smooth containing 3 mg nicotine per portion (alternative manufacturing process)
4. ZYN Smoo
Sponsors
Swedish Match North Europe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Snus user, with a minimum weekly consumption of three or more snus cans (brands with nicotine content 1%) since =1 year 2. Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure 3. Healthy male/female, age =19 4. Willing and able to comply with study procedures 5. A heart rate increase = 10 beats/min with first use of snus in the morning after overnight abstinence from any nicotine exposure
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 judgment 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. Pregnancy or planning to get pregnant during the study 7. Positive screen for drugs of abuse at screening or on admission to the unit prior to administration of the investigational product. 8. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) 9. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse 10. Use of any prescribed or non-prescribed medication including antacids, analgesics and herbal remedies within two weeks prior to the first administration of IP, except occasional intake of paracetamol (maximum 2 000 mg/day; and not exceeding 3 000 mg/week), at the discretion of the Investigator 11. Plasma donation within 1 month of Screening or any blood donation/blood loss >450 mL during the 3 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 one single dose of a novel, non-tobacco-based nicotine pouch containing 3 and 6 mg of nicotine, to that of one single dose from a 1 g Swedish snus pouch containing 8 mg of nicotine, is calculated based on measurement of nicotine in blood samples with a LC-MS/MS analytical method at the completion of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. AUC60min, Cmax, Tmax, AUCo-t and terminal half-life of a novel, non-tobacco-based nicotine pouch to that of a Swedish snus pouch is calculated based on measurement of nicotine in blood samples with a LC-MS/MS analytical method at the completion of the study 2. In-vivo extracted amount of nicotine from each portion, measured by subtracting the residual amount after use from the mean of 10 unused portions at completion of the study 3. The correlation between the estimates of AUC(inf) and the total amount of nicotine extracted from the ZYN® pouches, measured by statistical evaluation of data 4. Pulse rate and ”head buzz” (head rush, ”hit”, feeling alert, overall ”product strength”) measured using a 100-mm visual analogue scale (VAS) anchored with ”not at all” to ”extremely” at preset time points up to 60 minutes (predose, + 5min, +10 min, + 15 min, +30 min, +60 min after each dose), respectively, after study product administration (proxy for systemic uptake) 5. Adverse events measured by patient interviews | — |
Countries
Sweden
Outcome results
None listed