A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products

A Randomised, Cross-over, Single-blind, Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products

This will be a randomised, cross-over, single-blind, confinement study conducted in 27 male or female snus or nicotine pouch users. The study will investigate 4 different nicotine containing products in a cross-over design, incorporating pharmacokinetic (PK) evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety and tolerability evaluation.

During the study participation, subjects will come for 2 visits to the clinic, including a screening visit and a 4-day confinement period. A final follow up end-of-study telephone call will be performed within a week of last product use.

Inclusion Criteria:

• BMI ≥ 18.0 and ≤ 30.0 kg/m2
• Clinically normal medical history
• User of snus or nicotine pouches for ≥1 year, with a minimum weekly use of 2 or more snus or nicotine pouch cans and who is willing and considered able to use brands with nicotine content in the range of 14 to 20 mg nicotine/pouch

Exclusion Criteria:

• History of any clinically significant disease or disorder
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of IP.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV
• Female subjects who are pregnant or breastfeeding
• Presence or history of drug or alcohol abuse
• Excessive caffeine consumption defined by a daily intake of >5 cups of caffeine containing beverages
• Intend to change nicotine-use habit or make a quit attempt within the next 3 months from the screening visit.