N/A
Completed N=27
A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products
Healthy Volunteers
Source: ClinicalTrials.gov NCT05452278 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Nicotine Cmax — 14.98; 13.43; 19.35; 13.85 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nicotine Cmax |
14.98; 13.43; 19.35; 13.85 | — |
| PRIMARY Nicotine AUCt |
36.48; 31.72; 48.44; 32.11 | — |
| SECONDARY Percentage of Orally Extracted of Nicotine |
19.10; 22.9; 21.9; 14.0 | — |
| SECONDARY Urge to Use Emax |
61.7; 57.7; 66.1; 52.7 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05452278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.