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

NCT05452278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-03-09

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Imperial Brands PLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-21
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05452278 on ClinicalTrials.gov