Healthy VolunteersNCT05452278
A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products
A study testing Product A, Product B and Product C in people with Healthy Volunteers, run by Imperial Brands PLC at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Product A, Product B and Product C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- 21 Oct 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- Product A, Product B, Product C, Product D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product AOther
Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes
Product BOther
Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes
Product COther
Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes
Product DOther
Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Product sequence ABCD | Experimental | Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D |
| Product sequence BCDA | Experimental | Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4 Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D |
| Product sequence CDAB | Experimental | Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4 Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D |
| Product sequence DABC | Experimental | Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4 Receives: Other: Product A; Other: Product B; Other: Product C; Other: Product D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Cmax
Maximum observed plasma nicotine concentration
Measured: 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
Measured: 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
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
Measured: 20 minutes
Urge to Use Emax
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start21 Oct 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial Brands PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452278
- Sponsor's protocol ID
- IB-OND-ZONEX-11
- Status last verified
- Feb 2026
- First submitted
- 6 Jul 2022
- Last updated
- 9 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41044396
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Cross-over, Single-blind, Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products
- ClinicalTrials.gov ID
- NCT05452278
- Acronym / sponsor ID
- IB-OND-ZONEX-11
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Imperial Brands PLCIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Posted 26 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Product sequence ABCD | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects 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 | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects 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 | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects 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 | Experimental | Other: Product A, Other: Product B, Other: Product C, Other: Product DSubjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4 |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Product ATobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes | Other | Product sequence ABCD, Product sequence BCDA, Product sequence CDAB, Product sequence DABC |
| Product BTobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes | Other | Product sequence ABCD, Product sequence BCDA, Product sequence CDAB, Product sequence DABC |
| Product CTobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes | Other | Product sequence ABCD, Product sequence BCDA, Product sequence CDAB, Product sequence DABC |
| Product DTobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes | Other | Product sequence ABCD, Product sequence BCDA, Product sequence CDAB, Product sequence DABC |
Primary outcome
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
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
2 secondary outcomes
Percentage of Orally Extracted of Nicotine
Time frame: 20 minutes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41044396Chapman 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.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product A, Product B and Product C in people with Healthy Volunteers, run by Imperial Brands PLC at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.