A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Nicotine Cmax
研究概览
简要总结
This is a randomised, cross-over, open-label, confinement study conducted in 24 adult male or female smokers of combustible cigarettes. The study investigates combustible and heated tobacco (HT) products in a cross-over design, including pharmacokinetic evaluation, subjective questionnaire assessments, as well as safety evaluation.
Subjects will perform a screening visit and 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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Reports smoking an average of at least 10 manufactured combustible (menthol or non-menthol) cigarettes per day for at least 12 months prior to Screening
- •Has a positive urine cotinine (>500 ng/mL) at Screening
- •Has an exhaled carbon monoxide >10 ppm at Screening
- •A female subject of childbearing potential must use contraception
- •Male subject must use contraception
排除标准
- •Has a history or presence of clinically significant disease or condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results.
- •Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening
- •Has a fever (>38.05°C) at Screening or check-in
- •Has a history or presence of drug or alcohol abuse within 24 months of Check-in
- •Pregnant or lactating females
- •Has used any prescription smoking cessation treatments within 3 months prior to Check-in
- •Is planning to quit smoking during the study or within the next 3 months
结局指标
主要结局
Nicotine Cmax
时间窗: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use
Maximum measured plasma nicotine concentration, baseline-adjusted
Nicotine AUCt
时间窗: 5 minutes pre-study product use and at 2, 4, 6, 8, 10, 15, 30, 45, 60, 120, and 240 minutes following the start of study product use
The area under the concentration time curve for nicotine, from time 0 to the last observed non-zero concentration, baseline-adjusted
次要结局
- Urge to Smoke Pre-Use(10 minutes prior to the start of the product use session)
- Urge to Smoke Post-Use(At 240 min following the start of study product use)
- Smoking Urges Emax(10 minutes prior to the start of the product use session, and at 4, 8, 15, 45, 60, 210 and 240 minutes following the start of study product use)