A Randomised, Cross-over, Single-blind, Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Nicotine AUCt
研究概览
简要总结
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.
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
- •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
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.
- •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.
研究组 & 干预措施
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
干预措施: Product A (Other)
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
干预措施: Product B (Other)
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
干预措施: Product C (Other)
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
干预措施: Product D (Other)
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
干预措施: Product A (Other)
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
干预措施: Product B (Other)
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
干预措施: Product C (Other)
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
干预措施: Product D (Other)
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
干预措施: Product A (Other)
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
干预措施: Product B (Other)
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
干预措施: Product C (Other)
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
干预措施: Product D (Other)
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
干预措施: Product A (Other)
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
干预措施: Product B (Other)
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
干预措施: Product C (Other)
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
干预措施: Product D (Other)
结局指标
主要结局
Nicotine AUCt
时间窗: 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
The area under the concentration-time curve for nicotine, from time 0 to the time of the last sampling timepoint
Nicotine Cmax
时间窗: 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
Maximum observed plasma nicotine concentration
次要结局
- Urge to Use Emax(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)
- Percentage of Orally Extracted of Nicotine(20 minutes)