Trial Outcomes & Findings for A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products (NCT NCT05452278)

NCT ID: NCT05452278

Last Updated: 2026-03-09

Results Overview

Maximum observed plasma nicotine concentration

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

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

Results posted on

2026-03-09

Participant Flow

Participant milestones

Participant milestones
Measure
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 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
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 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
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 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
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 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
Overall Study
STARTED
7
7
7
6
Overall Study
COMPLETED
7
7
7
6
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Product Sequence ABCD
n=7 Participants
Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
Product Sequence BCDA
n=7 Participants
Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
Product Sequence CDAB
n=7 Participants
Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
Product Sequence DABC
n=6 Participants
Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes
Total
n=27 Participants
Total of all reporting groups
Age, Continuous
29.4 years
STANDARD_DEVIATION 10.2 • n=68 Participants
32.4 years
STANDARD_DEVIATION 14.4 • n=69 Participants
30.1 years
STANDARD_DEVIATION 10.0 • n=137 Participants
32.5 years
STANDARD_DEVIATION 15.0 • n=565 Participants
31.1 years
STANDARD_DEVIATION 11.8 • n=127 Participants
Sex: Female, Male
Female
4 Participants
n=68 Participants
1 Participants
n=69 Participants
4 Participants
n=137 Participants
2 Participants
n=565 Participants
11 Participants
n=127 Participants
Sex: Female, Male
Male
3 Participants
n=68 Participants
6 Participants
n=69 Participants
3 Participants
n=137 Participants
4 Participants
n=565 Participants
16 Participants
n=127 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=68 Participants
0 Participants
n=69 Participants
0 Participants
n=137 Participants
0 Participants
n=565 Participants
0 Participants
n=127 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
n=68 Participants
7 Participants
n=69 Participants
7 Participants
n=137 Participants
6 Participants
n=565 Participants
27 Participants
n=127 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=68 Participants
0 Participants
n=69 Participants
0 Participants
n=137 Participants
0 Participants
n=565 Participants
0 Participants
n=127 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=68 Participants
0 Participants
n=69 Participants
0 Participants
n=137 Participants
0 Participants
n=565 Participants
0 Participants
n=127 Participants
Race (NIH/OMB)
Asian
0 Participants
n=68 Participants
2 Participants
n=69 Participants
1 Participants
n=137 Participants
0 Participants
n=565 Participants
3 Participants
n=127 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=68 Participants
0 Participants
n=69 Participants
0 Participants
n=137 Participants
0 Participants
n=565 Participants
0 Participants
n=127 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=68 Participants
0 Participants
n=69 Participants
1 Participants
n=137 Participants
0 Participants
n=565 Participants
2 Participants
n=127 Participants
Race (NIH/OMB)
White
6 Participants
n=68 Participants
5 Participants
n=69 Participants
5 Participants
n=137 Participants
6 Participants
n=565 Participants
22 Participants
n=127 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=68 Participants
0 Participants
n=69 Participants
0 Participants
n=137 Participants
0 Participants
n=565 Participants
0 Participants
n=127 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=68 Participants
0 Participants
n=69 Participants
0 Participants
n=137 Participants
0 Participants
n=565 Participants
0 Participants
n=127 Participants

PRIMARY outcome

Timeframe: 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

Population: The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.

Maximum observed plasma nicotine concentration

Outcome measures

Outcome measures
Measure
Product A
n=27 Participants
All subjects further to use of Product A
Product B
n=26 Participants
All subjects further to use of Product B
Product C
n=26 Participants
All subjects further to use of Product C
Product D
n=27 Participants
All subjects further to use of Product D
Nicotine Cmax
14.98 ng/mL
Standard Deviation 4.96
13.43 ng/mL
Standard Deviation 4.97
19.35 ng/mL
Standard Deviation 6.58
13.85 ng/mL
Standard Deviation 3.85

PRIMARY outcome

Timeframe: 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

Population: The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.

The area under the concentration-time curve for nicotine, from time 0 to the time of the last sampling timepoint

Outcome measures

Outcome measures
Measure
Product A
n=27 Participants
All subjects further to use of Product A
Product B
n=26 Participants
All subjects further to use of Product B
Product C
n=26 Participants
All subjects further to use of Product C
Product D
n=27 Participants
All subjects further to use of Product D
Nicotine AUCt
36.48 h*ng/mL
Standard Deviation 12.72
31.72 h*ng/mL
Standard Deviation 9.50
48.44 h*ng/mL
Standard Deviation 19.68
32.11 h*ng/mL
Standard Deviation 9.46

SECONDARY outcome

Timeframe: 20 minutes

Population: The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.

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

Outcome measures

Outcome measures
Measure
Product A
n=27 Participants
All subjects further to use of Product A
Product B
n=27 Participants
All subjects further to use of Product B
Product C
n=27 Participants
All subjects further to use of Product C
Product D
n=27 Participants
All subjects further to use of Product D
Percentage of Orally Extracted of Nicotine
19.10 Percentage of nicotine
Standard Deviation 9.98
22.9 Percentage of nicotine
Standard Deviation 10.3
21.9 Percentage of nicotine
Standard Deviation 9.77
14.0 Percentage of nicotine
Standard Deviation 4.63

SECONDARY outcome

Timeframe: 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

Population: The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.

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).

Outcome measures

Outcome measures
Measure
Product A
n=27 Participants
All subjects further to use of Product A
Product B
n=27 Participants
All subjects further to use of Product B
Product C
n=25 Participants
All subjects further to use of Product C
Product D
n=26 Participants
All subjects further to use of Product D
Urge to Use Emax
61.7 mm
Standard Deviation 23.3
57.7 mm
Standard Deviation 19.7
66.1 mm
Standard Deviation 22.4
52.7 mm
Standard Deviation 25.7

Adverse Events

Product A

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Product B

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Product C

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Product D

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Product A
n=27 participants at risk
All subjects further to use of Product A
Product B
n=27 participants at risk
All subjects further to use of Product B
Product C
n=27 participants at risk
All subjects further to use of Product C
Product D
n=27 participants at risk
All subjects further to use of Product D
Eye disorders
Photophobia
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Respiratory, thoracic and mediastinal disorders
Epistaxis
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
General disorders
Fatigue
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Infections and infestations
Nasopharyngitis
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Gastrointestinal disorders
Constipation
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Gastrointestinal disorders
Flatulence
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Gastrointestinal disorders
Nausea
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Gastrointestinal disorders
Vomiting
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Nervous system disorders
Disturbance in attention
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
7.4%
2/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Nervous system disorders
Dizziness
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
Nervous system disorders
Headache
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
14.8%
4/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
3.7%
1/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
0.00%
0/27 • 7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.

Additional Information

Libby Clarke

Imperial Brands PLC

Phone: +44 (0117) 3320221

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place