Tobacco/nicotine use Not Applicable
Conditions
Interventions
Investigational Product (IP) and dosage (oral smokeless nicotine pouch)
ZYN Moist Wintergreen (1)* containing 9 mg nicotine/pouch
ZYN Moist Wintergreen (2)* containing 9 mg nicotine/pouch
ZYN Moist Ch
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. Male or female subject aged =19 years 3. Subject who has used oral tobacco/nicotine products for =1 year, with a minimum daily consumption of five or more snus pouches, and is willing and able to use brands with nicotine content =1% 4. Women of child bearing potential (WOCBP) must be willing to use a sufficient contraceptive 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. Any surgical or medical condition including abnormal salivation (also pharmaceutically induced), or history thereof, which, in the judgment of the Investigator, might interfere with the absorption of the IP 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 2. Any clinically significant illness in the 28 days prior to the first IP administration 3. A history or presence of untreated diagnosed hypertension or any cardiovascular disease 4. Female subject currently breast feeding, pregnant or planning to get pregnant during the study 5. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to first administration of the IP 6. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse, as judged by the Investigator 7. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extracted dose of nicotine from each portion is measured by using GC-MS analysis and calculated by subtracting the residual amount after use from the mean of 10 unused portions. Used portions are freezed after dosing and analysis using GC-MS is performed at the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The extracted dose of flavor components are measured using GC-MS analysis and calculated by subtracting the residual amount after use from the mean of 10 unused portions. Used portions are freezed after dosing and analysis using GC-MS is performed at the end of the study 2. Self-report of potential adverse events (AEs, frequency, intensity and seriousness) measured throughout the study | — |
Countries
Sweden
Outcome results
None listed