A Randomised, Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product, a Nicotine Inhalator and a Conventional Cigarette
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Nicotine Plasma Concentration
研究概览
简要总结
Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are otherwise known as electronic cigarettes. These may look like conventional cigarettes but do not contain tobacco.
The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.
This trial is to evaluate the pharmacokinetic profile of an EVP.
详细描述
The principal part of this study evaluates the nicotine pharmacokinetic profile of conventional cigarettes, a nicotine inhalator, an unflavoured EVP and a flavoured EVP.
A second part investigates the nicotine delivery of an EVP with four different nicotine doses.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI of 18-35kg/m2
- •Subjects must be established smokers
- •Subjects must have smoked five to 30 cigarettes per day for at least one year
排除标准
- •Subjects who have used nicotine replacement therapy within 14 days of the screening
- •Subjects who have donated blood within 12 months preceding study
- •Subjects with relevant illness history
- •Subjects positive for hepatitis or HIV
- •Subjects with history of drug or alcohol abuse
- •Subjects with lung function test or vital signs considered unsuitable
- •Subjects who are trying to stop smoking
研究组 & 干预措施
Sequence 1
Subjects use the unflavoured EVP on Day 1, the flavoured EVP on Day 2, the nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
干预措施: EVP flavoured (Other)
Sequence 1
Subjects use the unflavoured EVP on Day 1, the flavoured EVP on Day 2, the nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
干预措施: EVP unflavoured (Other)
Sequence 1
Subjects use the unflavoured EVP on Day 1, the flavoured EVP on Day 2, the nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
干预措施: Nicotine inhalator (Other)
Sequence 1
Subjects use the unflavoured EVP on Day 1, the flavoured EVP on Day 2, the nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
干预措施: Conventional cigarette (Other)
Sequence 2
Subjects use the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.
干预措施: Conventional cigarette (Other)
Sequence 2
Subjects use the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.
干预措施: EVP unflavoured (Other)
Sequence 2
Subjects use the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.
干预措施: EVP flavoured (Other)
Sequence 2
Subjects use the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.
干预措施: Nicotine inhalator (Other)
Sequence 3
Subjects use the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
干预措施: EVP unflavoured (Other)
Sequence 3
Subjects use the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
干预措施: EVP flavoured (Other)
Sequence 3
Subjects use the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
干预措施: Nicotine inhalator (Other)
Sequence 3
Subjects use the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
干预措施: Conventional cigarette (Other)
Sequence 4
Subjects use the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.
干预措施: Conventional cigarette (Other)
Sequence 4
Subjects use the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.
干预措施: EVP unflavoured (Other)
Sequence 4
Subjects use the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.
干预措施: EVP flavoured (Other)
Sequence 4
Subjects use the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.
干预措施: Nicotine inhalator (Other)
结局指标
主要结局
Nicotine Plasma Concentration
时间窗: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours
Maximum plasma nicotine concentration (Cmax)
Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)
时间窗: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours
次要结局
- Exhaled Carbon Monoxide(25 minutes)
- Nicotine Withdrawal Symptoms(30 minutes after the third product use)
- Nicotine Craving(30 minutes after the third product use)