A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products

February 23, 2026 updated by: Imperial Brands PLC

A Randomised, Cross-over, Single-blind, Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, SE-752 37
        • CTC Clinical Trial Consultants AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Product sequence ABCD
Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4
Other: Product A
Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes
Other: Product B
Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes
Other: Product C
Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes
Other: Product D
Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
Experimental: Product sequence BCDA
Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4
Other: Product A
Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes
Other: Product B
Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes
Other: Product C
Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes
Other: Product D
Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
Experimental: Product sequence CDAB
Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4
Other: Product A
Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes
Other: Product B
Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes
Other: Product C
Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes
Other: Product D
Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
Experimental: Product sequence DABC
Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4
Other: Product A
Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes
Other: Product B
Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes
Other: Product C
Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes
Other: Product D
Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nicotine Cmax
Time Frame: 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
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
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urge to Use Emax
Time Frame: 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
The subjects will self-assess their urge to use a nicotine pouch, pre-use and after use, by answering the question: "How strong is your urge to use a nicotine pouch right now?" on a 100 mm visual analogue scale (VAS), with the anchor points 0 mm (= not at all/no urge) and 100 mm (= extremely/extreme urge). Emax is the maximum change from baseline VAS score (VASpre-use - VASpost-use).
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
Percentage of Orally Extracted of Nicotine
Time Frame: 20 minutes

The percentage of orally extracted nicotine from each pouch after 20 minutes of product use is calculated by subtracting the amount of nicotine left in the study pouches after use, to the amount of nicotine in unused reference pouches.

Extracted dose of nicotine was assessed by the formula:

(A*B)/C - D where A = Reference value of nicotine as assessed by the average of extracted nicotine in unused reference pouches B = Weight of the unused pouch C = Reference weight value as assessed by the average of weight for unused reference pouches D = Extracted nicotine of the used pouch
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial Brands PLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2021

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

July 6, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB-OND-ZONEX-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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