Nicotine uptake Not Applicable
Conditions
Interventions
The following products will be administered in the study as 60-minute single product administrations:
1. Swedish Snus (pouch) – Granit Vit Stark with 13 mg/pouch nicotine
Sponsors
British American Tobacco (Investments)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy daily user of smokeless snus or modern oral nicotine products aged 19-55 years
Exclusion criteria
Exclusion criteria: 1. Female who is lactating at screening 2. Female who is pregnant according to the pregnancy test at screening or prior to the first study product administration 3. Presence of braces, partials, dentures or any dental work that could, in the opinion of an investigator, affect the conduct of the study (including missing molars) 4. Presence or history of significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction 5. History of significant hypersensitivity to any excipients of the formulations as well as severe hypersensitivity reactions (like angioedema) to any drugs 6. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect nicotine bioavailability 7. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease 8. Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment 9. Maintenance therapy with any drug (with the exception of hormonal contraceptives or hormone replacement therapy) or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic) 10. Any clinically significant illness in the 28 days prior to the first study product administration 11. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study product administration, that in the opinion of an investigator would put into question the status of the participant as healthy 12. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Champix®), bupropion (Wellbutrin®, Zyban®), or Lobelia extract in the 28 days prior to the first study product administration 13. Any history of tuberculosis 14. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first product administration 15. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests 16. Previous inclusion in this clinical study 17. Intake of an Investigational Product (IP) in any other clinical study in the 28 days prior to the first study product administration 18. Subjects who have donated: 18.1. =400 mL of blood within 90 days prior to admission 18.2. Plasma in the 7 days prior to admission 18.3. Platelets in the 6 weeks prior to administration 19. Postponement of a decision to quit using tobacco- or nicotine-containing products in order to participate in this study 20. Previously attempted to quit using tobacco- or nicotine-containing products in the 28 days prior to the first study product administration 21. Employees or immediate relatives of the tobacco industry or the clinical site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma nicotine levels analysed for the following parameters using blood samples pre-dose (up to 5 minutes before the product use), and then at 5, 10, 20, 40, 60, 65, 75, 90, 120, 240 and 360 minutes following the start of administration: 1. Cmax 2. AUC0-6h | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Product liking assessment, assessed using the Subjective Product Liking Questionnaire (PLQ) following product use 2. Intent to use product again, assessed using the Overall Intent to Use Again (OIUA) questionnaire following product use 3. Mouth Levels Exposure (MLE), assessed by measuring nicotine levels in pouches after use in PK session for comparison to unused products | — |
Countries
Sweden
Contacts
Public ContactMarika Kvarmstrom
Outcome results
None listed