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

Imperial Brands

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Product B; Other: Product A; Other: Product C; Other: Product D

Study type: Interventional

Funder types: Industry

Identifiers

NCT05452278

IB-OND-ZONEX-11

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 19 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 4 patient groups

Product sequence ABCD

Experimental group

Description:

Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4

Treatment:

Other: Product D

Other: Product C

Other: Product A

Other: Product B

Product sequence BCDA

Experimental group

Description:

Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4

Treatment:

Other: Product D

Other: Product C

Other: Product A

Other: Product B

Product sequence CDAB

Experimental group

Description:

Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4

Treatment:

Other: Product D

Other: Product C

Other: Product A

Other: Product B

Product sequence DABC

Experimental group

Description:

Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4

Treatment:

Other: Product D

Other: Product C

Other: Product A

Other: Product B