Oral nicotine use Not Applicable
Conditions
Interventions
Test Product: Nicotine Pouch, 4 mg
Reference Product 1: Nicotine Gum, 4 mg
Reference Product 2: Nicotine Lozenge, 4 mg
Eligible subjects will undergo a
Sponsors
British American Tobacco (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/07/2020: 1. Provision of signed and dated informed consent form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Healthy adult male or female 4. If female, meets one of the following criteria: 4.1 Is of childbearing potential and agrees to use two of the accepted contraceptive regimens from at least 28 days prior to the first study product administration through to at least 30 days after the last dose of study product. An acceptable method of contraception includes one of the following: -Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch) -intrauterine device (with or without hormones) -Barrier methods of contraception (male condom with spermicide, female condom, cervical cap, diaphragm, contraceptive sponge) -Male partner vasectomized at least 6 months prior to the first study product administration Or 4.2. Is of childbearing potential and agrees to abide by true abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle (not periodic abstinence) Or 4.3. Male partner has had a vasectomy less than 6 months prior to dosing, and agrees to use an additional acceptable contraceptive method from the first study product administration through to at least 30 days after the last dose of study product Or 4.4. Is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study product administration) 5. Aged at least 19 years but not older than 55 years 6. Body mass index (BMI) within 18.5 kg/m² to 30.0 kg/m², inclusively 7. Minimal body weight of 50 kg 8. Primary tobacco product used in the last 6 months is combustible cigarettes or roll-your-own cigarettes 9. A smoker of 10 cigarettes or more >6 mg ISO tar per day who has smoked for at least 6 months prior to the first study product administration 10. Stated willingness to abstain from nicotine and tobacco products (except for the study products provided) from 24 hours prior to the first study product administration until the end of the study 11. Positive urine cotinine test (=200 ng/mL) at screening and prior to the first study product administration 12. Successful completion of the training session for study product use prior to the first study product administration (subject is able to follow the instructions and does not experience adverse events during the training session) 13. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator 14. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including oral mucosa examination and vital
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 any tongue piercings or history of any tongue piercings in the last 90 days prior to the first study product administration 4. 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) 5. Presence or history of significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction 6. History of significant hypersensitivity to any excipients of the formulations as well as severe hypersensitivity reactions (like angioedema) to any drugs 7. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability 8. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease 9. Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment 10. 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) 11. Any clinically significant illness in the 28 days prior to the first study product administration 12. 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 13. Use of pseudoephedrine in the 7 days prior to the first study product administration 14. 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 (Chantix®), bupropion (Wellbutrin®, Zyban®), or Lobelia extract in the 28 days prior to the first study product administration 15. Any history of tuberculosis 16. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first product administration 17. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests 18. Inclusion in a previous group for this clinical study 19. Intake of an Investigational Product (IP) in any other clinical trial in the 28 days prior to the first study product administration 20. Donation of 50 mL or more of blood in the 28 days prior to the first study product administration 21. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study product administration 22. Postponement of a decision to quit using tobacco- or nicotine-containing products in order to participate in this study 23. Previously attempted to quit using tobacco- or nicotin
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Bioequivalence of Test product compared to Reference products within the 80.0 to 125.0% bioequivalence range measured as above. | — |
Primary
| Measure | Time frame |
|---|---|
| Measured by PK blood samples will be collected at 0, 5, 10, 20, 30, 40, 50 min and 1, 1.25, 2, 3, 4, 5, 6, 8, 9, 10, 11, and 12 hours: Cmax and AUC0-T of nicotine | — |
Countries
Canada
Outcome results
None listed