A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Nasal Spray
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS
研究概览
简要总结
The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is aged from 22 to 65 years (inclusive).
- •Smoking, healthy subject as judged by the Investigator.
- •Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.
- •Subject has smoked for at least the last 3 consecutive years.
排除标准
- •As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
- •Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.
- •Female subject is pregnant or breast feeding.
- •Female subject does not agree to use an acceptable method of effective contraception.
研究组 & 干预措施
mTHS 2.2 then mCC
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of mTHS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of mCC).
干预措施: mTHS 2.2 (Other)
mCC then mTHS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of mCC)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of mTHS 2.2).
干预措施: mTHS 2.2 (Other)
mTHS 2.2 then NNS
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of mTHS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single administration of NNS)
干预措施: mTHS 2.2 (Other)
mTHS 2.2 then NNS
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of mTHS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single administration of NNS)
干预措施: NNS (Other)
NNS then mTHS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single administration of NNS)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of mTHS 2.2).
干预措施: mTHS 2.2 (Other)
NNS then mTHS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single administration of NNS)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of mTHS 2.2).
干预措施: NNS (Other)
mCC then mTHS 2.2
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of mCC)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of mTHS 2.2).
干预措施: mCC (Other)
mTHS 2.2 then mCC
Each subject will follow the below study design:
- Day 0 = Wash-out (1 day)
- Day 1 = 1st intervention (single product use of mTHS 2.2)
- Day 2 = wash-out
- Day 3 = 2nd intervention (single product use of mCC).
干预措施: mCC (Other)
结局指标
主要结局
Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS
时间窗: 3 days
Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use). Geometric Least Squares (geometric LS) means are provided.
Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS
时间窗: 3 days
Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use). Geometric Least Squares means are provided.
次要结局
未报告次要终点