Nicotine Pharmacokinetics and Subjective Effects of 9 Nordic Spirit Nicotine Pouch Products in Adult Cigarette Smokers: A Controlled, Randomized, Cross-over Study With a Balanced Incomplete Block Design.
JT International SA
Summary
Nicotine pharmacokinetics and subjective effects of 9 Nordic Spirit Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.
Description
To characterize nicotine pharmacokinetic (PK) parameters following a single ad libitum administration of 9 Nordic Spirit nicotine pouches (NPs) relative to usual brand combustible cigarette (UBCC), Nicorette (NRT) gum, and a comparator NP product.
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Voluntary consent to participate in this study documented on the signed ICF. 2. Healthy adult males and females ≥22 and ≤65 years of age, at screening. 3. Smokers and smokers that use other tobacco products (i.e., snus, moist snuff, Electronic Nicotine Delivery Systems, NP) will be considered. Smoking history (self-reported at screening) of an average of at least 5 but no more than 30 factory-manufactured combustible cigarettes daily for at least 12 months prior to screening. Brief periods (i.e., up to 7 consecutive days) of nonsmoking during the 3 months prior to scree…
Interventions
- DrugParticipants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.
Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. The pouch is not to be swallowed, chewed or broken. At the end of the 30-minute period, participants will remove the pouch and the study staff will collect and dispose of it accordingly. Nicotine pouches deliver nicotine through the mucous membranes of the mouth.
Locations (2)
- AMRKnoxville, Tennessee
- ICON San AntonioSan Antonio, Texas