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
1 other identifier
interventional
27
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy-volunteers
Started Oct 2021
Typical duration for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2021
CompletedFirst Submitted
Initial submission to the registry
July 6, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedResults Posted
Study results publicly available
September 26, 2025
CompletedMarch 9, 2026
February 1, 2026
1.8 years
July 6, 2022
September 8, 2025
February 23, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Nicotine Cmax
Maximum observed plasma nicotine concentration
5 minutes prior to product use and 5, 10, 15, 20, 25, 30, 45, 60, 90 minutes, 2, 4, 6 and 8 hours post start of product use
Nicotine AUCt
The area under the concentration-time curve for nicotine, from time 0 to the time of the last sampling timepoint
5 minutes prior to product use and at 5, 10, 15, 20, 25, 30, 45, 60, 90 minutes, 2, 4, 6 and 8 hours post start of product use
Secondary Outcomes (2)
Percentage of Orally Extracted of Nicotine
20 minutes
Urge to Use Emax
5 minutes prior to product use and at 5, 10, 15, 20, 25, 30, 45 minutes, and 1, 1.5, 2, 4, 6 and 8 hours post start of product use
Study Arms (4)
Product sequence ABCD
EXPERIMENTALSubjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4
Product sequence BCDA
EXPERIMENTALSubjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4
Product sequence CDAB
EXPERIMENTALSubjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4
Product sequence DABC
EXPERIMENTALSubjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4
Interventions
Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes
Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes
Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes
Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CTC Clinical Trial Consultants AB
Uppsala, SE-752 37, Sweden
Related Publications (1)
Chapman F, Morrissey R, McDermott S, Cahours X, Verron T, Taverner V, Stevenson M, Nahde T. Evaluation of high-nicotine oral products shows potential to reduce tobacco-related harm by offering satisfying alternatives. Sci Rep. 2025 Oct 3;15(1):34636. doi: 10.1038/s41598-025-21812-x.
PMID: 41044396DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Libby Clarke
- Organization
- Imperial Brands PLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2022
First Posted
July 11, 2022
Study Start
October 21, 2021
Primary Completion
July 31, 2023
Study Completion
July 31, 2023
Last Updated
March 9, 2026
Results First Posted
September 26, 2025
Record last verified: 2026-02