Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine Administered by Electronic Cigarette and Cigarette
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve (AUC 0-24h)
研究概览
简要总结
The purposes of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.
详细描述
Electronic cigarettes (e-cigarettes) are battery-operated devices that deliver nicotine via inhaled vapour or "vaping". At present, e-cigarettes are becoming increasingly popular among smokers worldwide. However, knowledge about e-cigarette nicotine pharmacology remains limited.
The aims of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Understanding and accepting the study procedures and signing the informed consent.
- •Male adults volunteers (18-45 years old).
- •Clinical history and physical examination demonstrating no organic or psychiatric disorders.
- •The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
- •Present use of nicotine without serious adverse reactions.
- •Smokers ≥ 3 cigarettes/day.
排除标准
- •Having suffered any cardiovascular and/or respiratory disease in the three months prior to the study start.
- •History of drug dependence (except for nicotine dependence).
- •Daily consumption >4 standard units of ethanol.
- •Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
- •Having suffered any organic disease or major surgery in the three months prior to the study start.
- •Blood donation 12 weeks before or participation in other clinical trials with drugs in the previous 12 weeks.
- •History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
- •Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
- •Use of any drug or substance inhibitor of cytochrome P-450-1A6 (CYP1A6) (p.e. raloxifene, coumarins, etc)
研究组 & 干预措施
Electronic cigarette
Multiple dose
Nicotine 0.8 mg, administrated by electronic cigarette (10 puffs) + Nicotine 0.8 mg, administrated by electronic cigarette (10 puffs) separated by 60 minutes
干预措施: Nicotine (Drug)
Cigarette
Multiple dose
Nicotine 0.8 mg, administrated by cigarette (10 puffs) + Nicotine 0.8 mg, administrated by cigarette (10 puffs) separated by 60 minutes
干预措施: Nicotine (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve (AUC 0-24h)
时间窗: From baseline (pre-dose, 0h) to 5, 15, 30, 45, 55, 65, 75, 90, 105, 120 and 24h post-dose
Calculation of AUC of the concentrations of nicotine and its metabolites in blood
次要结局
- Changes in heart rate(From pre-dose (baseline) to 120 min post-dose)
- Changes in expired carbon monoxide (CO) aire(From pre-dose (baseline) to 120 min post-dose)
- Changes in nicotine abstinence symptoms(From pre-dose (baseline) to 120 min post-dose)
- Number of Participants with Serious and Non-Serious Adverse Events(2 days after each substance administration)
- Elimination half-life(From baseline to 24h post-dose)
- Changes in blood pressure(From pre-dose (baseline) to 120 min post-dose)
- Area Under the Concentration-Time Curve (AUC 0-24h)(From baseline (pre-dose, 0h) to 15, 30, 45, 55, 65, 75, 90, 105, 120 min, 6, 12 and 24h)
- Changes in pupil diameter(From pre-dose (baseline) to 120 min post-dose)
- Changes in oral temperature(From pre-dose (baseline) to 120 min post-dose)
- Changes in subjective effects(From pre-dose (baseline) to 120 min post-dose)