A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products

Inclusion criteria

• Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m
• Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator
• Dual user of snus and conventional cigarettes for ≥1 year, with a minimum weekly consumption of two or more snus cans and >5 cigarettes, and who is willing and able to use brands with nicotine content ≥1%

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
• Positive for HIV, hepatitis B or C
• After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:

• Systolic blood pressure <90 or >140 mmHg, or
• Diastolic blood pressure <50 or >90 mmHg, or
• Pulse <40 or >90 bpm
• Alcohol or drug abuse
• Use, or history of use of anabolic steroids
• Allergy/hypersensitivity to drugs with a similar chemical structure or class to nicotine
• Excessive caffeine consumption (daily intake of >5 cups)
• Female subjects who are pregnant or breastfeeding