A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-01-20

Brief Summary

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This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a cross-over fashion. The study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation.

During the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ABCDE

Subjects use product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes on Day 1, then switch to use product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 min on Day 2, then product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 min on Day 3, then D (nicotine pouch, 10.6 mg/pouch) on Day 4 and finally E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette), smoked in approximately 5 minutes with puffs taken at regular intervals approximately 30 seconds apart, on Day 5.

Subjects can use their assigned product ad libitum on each study day, after all study assessments are performed, until 10pm. A washout period of product abstinence is observed between products, overnight.

Group Type OTHER

A

Intervention Type OTHER

Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes

B

Intervention Type OTHER

Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes

C

Intervention Type OTHER

Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes

D

Intervention Type OTHER

Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes

E

Intervention Type OTHER

Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes

BCDEA

Same as previous arm but in a different randomization order.

Group Type OTHER

A

Intervention Type OTHER

Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes

B

Intervention Type OTHER

Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes

C

Intervention Type OTHER

Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes

D

Intervention Type OTHER

Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes

E

Intervention Type OTHER

Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes

CDEAB

Same as previous arm but in a different randomization order.

Group Type OTHER

A

Intervention Type OTHER

Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes

B

Intervention Type OTHER

Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes

C

Intervention Type OTHER

Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes

D

Intervention Type OTHER

Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes

E

Intervention Type OTHER

Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes

DEABC

Same as previous arm but in a different randomization order.

Group Type OTHER

A

Intervention Type OTHER

Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes

B

Intervention Type OTHER

Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes

C

Intervention Type OTHER

Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes

D

Intervention Type OTHER

Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes

E

Intervention Type OTHER

Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes

EABCD

Same as previous arm but in a different randomization order.

Group Type OTHER

A

Intervention Type OTHER

Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes

B

Intervention Type OTHER

Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes

C

Intervention Type OTHER

Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes

D

Intervention Type OTHER

Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes

E

Intervention Type OTHER

Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes

Interventions

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A

Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes

Intervention Type OTHER

B

Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes

Intervention Type OTHER

C

Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes

Intervention Type OTHER

D

Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes

Intervention Type OTHER

E

Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes

Intervention Type OTHER

Other Intervention Names

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Product A Product B Product C Product D Product E

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m
* Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator
* Dual user of snus and conventional cigarettes for ≥1 year, with a minimum weekly consumption of two or more snus cans and \>5 cigarettes, and who is willing and able to use brands with nicotine content ≥1%

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
* Positive for HIV, hepatitis B or C
* After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:

* Systolic blood pressure \<90 or \>140 mmHg, or
* Diastolic blood pressure \<50 or \>90 mmHg, or
* Pulse \<40 or \>90 bpm
* Alcohol or drug abuse
* Use, or history of use of anabolic steroids
* Allergy/hypersensitivity to drugs with a similar chemical structure or class to nicotine
* Excessive caffeine consumption (daily intake of \>5 cups)
* Female subjects who are pregnant or breastfeeding

Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes