Nicotine use Other
Conditions
Interventions
Investigational products (IPs):
NP Dry (3 mg) – Reference
NP Dry (3 mg) – Prototype A
NP Dry (3 mg) – Prototype B
Subjects will report to the test laboratory for a screening visit, followed by thr
Sponsors
Swedish Match North Europe AB
Eligibility
Sex/Gender
All
Age
21 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to give written informed consent for participation in the study 2. Subjects who have used NPs or tobacco-based snus for =1 year, with a minimum weekly consumption of three cans 3. Healthy male or female subject aged =21 to =55 years 4. Normal stimulated salivary secretion rate (>0.7 mL/min) 5. At least 24 own teeth remaining and overall good oral health, as judged by the Investigator 6. Women of child-bearing potential must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of <1% to prevent pregnancy for the duration of the study. The following are considered highly effective methods of contraception: 6.1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) 6.2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) 6.3. Intrauterine device or intrauterine hormone-releasing system
Exclusion criteria
Exclusion criteria: 1. A history of diagnosed hypertension or any cardiovascular disease, or ongoing manifestations of hypertension or any cardiovascular disease as judged by the Investigator. 2. 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, distribution, metabolism or excretion 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. 3. Subjects who are pregnant, breastfeeding, or intend to become pregnant during the course of the study. 4. A history of diagnosed severe allergy/hypersensitivity or ongoing manifestations of severe allergy/hypersensitivity to aroma compounds (including fragrances and/or flavorings), as judged by the Investigator. 5. Subjects with severe oral conditions such as open caries lesions, severe periodontal health, lesions in soft tissues (apart from oral mucosal lesions related to the use of snus), or extensive prosthetic work (e.g., several implants, partial denture, dental veneers). 6. Any planned major surgery within the duration of the study. 7. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse, as judged by the Investigator. 8. Antibiotic use =4 weeks prior to the screening period. 9. Subjects who intend to change their nicotine consumption habit, including the intention to stop using nicotine products, within the next 3 months of the screening visit, as judged by the Investigator. 10. Subjects undergoing other dental treatment during the study period. 11. The Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements.
Countries
Sweden
Contacts
Public ContactCamilla Pramfalk
Outcome results
None listed