A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products (Traditional Snus, Conventional Cigarette and Three Oral Tobacco-free Nicotine Delivery Products)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Nicotine Cmax
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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%
排除标准
- •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
研究组 & 干预措施
CDEAB
Same as previous arm but in a different randomization order.
干预措施: B (Other)
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.
干预措施: A (Other)
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.
干预措施: B (Other)
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.
干预措施: E (Other)
BCDEA
Same as previous arm but in a different randomization order.
干预措施: A (Other)
BCDEA
Same as previous arm but in a different randomization order.
干预措施: B (Other)
BCDEA
Same as previous arm but in a different randomization order.
干预措施: E (Other)
CDEAB
Same as previous arm but in a different randomization order.
干预措施: A (Other)
CDEAB
Same as previous arm but in a different randomization order.
干预措施: E (Other)
DEABC
Same as previous arm but in a different randomization order.
干预措施: A (Other)
DEABC
Same as previous arm but in a different randomization order.
干预措施: B (Other)
DEABC
Same as previous arm but in a different randomization order.
干预措施: E (Other)
EABCD
Same as previous arm but in a different randomization order.
干预措施: A (Other)
EABCD
Same as previous arm but in a different randomization order.
干预措施: B (Other)
EABCD
Same as previous arm but in a different randomization order.
干预措施: E (Other)
CDEAB
Same as previous arm but in a different randomization order.
干预措施: C (Other)
EABCD
Same as previous arm but in a different randomization order.
干预措施: D (Other)
EABCD
Same as previous arm but in a different randomization order.
干预措施: C (Other)
DEABC
Same as previous arm but in a different randomization order.
干预措施: D (Other)
DEABC
Same as previous arm but in a different randomization order.
干预措施: C (Other)
CDEAB
Same as previous arm but in a different randomization order.
干预措施: D (Other)
BCDEA
Same as previous arm but in a different randomization order.
干预措施: D (Other)
BCDEA
Same as previous arm but in a different randomization order.
干预措施: C (Other)
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.
干预措施: D (Other)
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.
干预措施: C (Other)
结局指标
主要结局
Nicotine Cmax
时间窗: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
Maximum plasma concentration of nicotine (Cmax)
Nicotine AUCt
时间窗: Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start
Area under the plasma nicotine concentration-time curve at the last timepoint measured (AUCt)
次要结局
- Nicotine Extraction(20 minutes)