An Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 Puff and Ad-libitum) Conditions, in Healthy Adult Smokers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
研究概览
简要总结
A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers
详细描述
E- cigarettes may be an acceptable alternative to traditional cigarette smoking. By utilizing vaporization rather than combustion, the generation and inhalation of HPHCs, smoke, and carbon monoxide (CO) may be reduced or avoided. This study will provide an understanding of the in vitro levels of nicotine obtained with use of the company's ENDS products compared to competitor products marketed in the United States of America (USA), and to a popular brand of combustible cigarette smoked in the USA.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18 to 60 years of age inclusive.
- •BMI between 18 to 35 kg / m2 inclusive.
- •Healthy based on medical history and screening assessments, in the opinion of the Investigator.
- •Current smoker of at least 8 cigarettes per day on average.
- •Has been smoking for at least 12 months prior to screening. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) are permitted at the discretion of the Investigator.
- •Able to participate, and willing to give written informed consent and comply with study restrictions.
排除标准
- •Clinically relevant medical or psychiatric disorder, in the opinion of the Investigator.
- •Clinically significant abnormality on screening ECG.
- •Sustained blood pressure recordings at screening of < 90 mmHg or > 150 mmHg for systolic blood pressure, or < 50 mmHg or > 90 mmHg for diastolic blood pressure.
- •Sustained resting heart rate of > 100 or < 40 beats per minute at screening.
- •Positive result for urine drugs of abuse test or alcohol breath test at screening. If a positive urine drug test is observed, and it is believed the positive urine test is due to prescription drugs, the PI should obtain documentation that a) confirms the subject's use of the prescribed medication, and b) the prescribed medication will cause a false positive drug test.
- •Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
- •Exposure to an investigational drug in a clinical trial within 1 month prior toAssessment Day
- •Blood or plasma donation of > 500 mL within 1 month prior to Assessment Day
- •Positive urine pregnancy test at screening or Assessment Day 1 in female subject.
- •Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
结局指标
主要结局
Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP.
时间窗: 48 days
To estimate nicotine pharmacokinetics (PK) profiles across 8 E-Cigarette/cigarette products within-each and between-all delivery conditions (10 puffs versus ad libitum puffs) using Area Under the nicotine concentration-time curve (AUC1hour) calculated using linear trapezoidal summation from time zero (defined as the start of product use) to 60 minutes.
次要结局
- Characterize consumption of 8 E-cigarettes/cigarettes products by collecting total number of puffs for each e-cigarette(48 days)
- Measure exhaled Carbon Monoxide change in all product administration periods(48 days)
- Characterize level of user Satisfaction for 8e-cigarette/cigarettes products using Modified Product Evaluation Scale(48 days)