Tobacco/nicotine use Other
Conditions
Interventions
Investigational Product (IP), dosage and mode of administration
1. ZYN Moist Smooth containing 7 mg nicotine per portion
2. ZYN Moist Smooth containing 9 mg nicotine per portion
3. ZYN Moist Smooth co
Sponsors
Swedish Match
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give written informed consent for participation in the study 2. Snus user who has used tobacco-based snus for =1 year, with a minimum weekly consumption of two or more snus cans, and is willing and able to usebrandsuse brands with nicotine content =1% 3. Healthy male or female subject aged =19 years 4. Women of childbearing potential (WOCBP) must be willing to use a sufficient contaceptive method for the duration of the study, this includes mechanical barrier (e.g., a male condom or a female diaphragm), combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal anticonception associated with inhibition of ovulation [oral, injectable, implantable], IUD or IUS. Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject
Exclusion criteria
Exclusion criteria: 1. Daily smoker, defined as smoking during the last 24 hours according to self-report 2. A history or presence of diagnosed hypertension or any cardiovascular disease 3. Any surgical or medical condition, or history thereof, which, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product or may either put the subject at risk because of participation in the study, influence the results, or the subject’s ability to participate in the study 4. Female subject currently breastfeeding, pregnant or planning to get pregnant during the study 5. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) 6. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to first administration of the IP 7. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse, as judged by the investigator 8. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening 9. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of nicotine in plasma: the difference in AUCinf based on plasma concentrations of nicotine from 0 – 6h after administration of a single dose of ZYN Moist 7 mg and a single dose of Longhorn 18 mg, 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. Pharmacokinetics of nicotine in plasma: Tmax, Cmax, AUCinf, AUC0- 1.5h and terminal elimination half-life of the non-tobacco-based nicotine ZYN Moist pouches, ZYN Dry Mini pouches and Longhorn 18 mg. Blood samples for analysis of PK parameters will be collected pre-dose, 5 min, 10 min, 15 min, 30 min, 45 min, 1h, 1h:15 min, 1h:30 min, 2h, 4h, 6h post-dose. The PK parameters in the study will include AUCinf, AUC0-t, Cmax, Tmax, and terminal half-life 2. In vivo extracted amount of nicotine (mg/unit) and extracted fraction (%) analysed at t=60 min (removal of pouch) using GC-MS analysis and calculated by subtracting the residual amount after use from the mean of 10 unused pouches. Used pouches are frozen after dosing and analysis using GC-MS is performed at the end of the trial. 3. The urge to snus, measured using a 100-mm visual analogue scale (VAS) anchored with ”not at all” to ”extremely” as answer to the question “Right now, how strong is your urge for snus?” at pre-set time points up to 60 min (-10 min pre-dose, -1 min pre-dose, 2 min, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 45 min, and 60 min after each dose) after start of the investigational product (IP) administration | — |
Countries
Sweden
Outcome results
None listed