This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a cross-over fashion. The study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation. During the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes
Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes
Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes
CTC Clinical Trial Consultants AB (CTC)
Uppsala, Sweden
Nicotine Cmax
Maximum plasma concentration of nicotine (Cmax)
Time frame: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
Nicotine AUCt
Area under the plasma nicotine concentration-time curve at the last timepoint measured (AUCt)
Time frame: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
Nicotine Extraction
Extraction fraction (%) of nicotine in used product pouches after 20 minutes of use.
Time frame: 20 minutes
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Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes
Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes