A Randomized, Open-label, Cross-over Clinical Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations in Adult Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Nicotine pharmacokinetics Cmax
研究概览
简要总结
This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label, cross-over clinical study conducted in 15 healthy US adult smokers.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having smoked ≥10 manufactured cigarettes per day for at least the last year
- •Expired carbon monoxide level of >10 ppm at screening
- •Tested positive for urinary cotinine (≥500 ng/mL)
排除标准
- •Known or suspected hypersensitivity to any component of the e-liquid formulations
- •Taking or receiving prescription smoking cessation medicines
- •Willing or considering to stop smoking
- •Smokers who draw smoke into their mouth and throat but do not inhale
- •Relevant illness history
- •Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
- •Breastfeeding women
- •Women of child-bearing potential who were not using an accepted method of contraception
研究组 & 干预措施
blu PRO 48 mg nicotine salt
blu PRO open-system containing 48 mg nicotine salt tobacco flavour
干预措施: blu PRO 48 mg nicotine salt (Other)
Conventional cigarette
The subject's preferred brand of commercially available conventional cigarette
干预措施: Conventional cigarette (Other)
myblu 25 mg freebase
myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour
干预措施: myblu 25 mg freebase (Other)
myblu 16 mg nicotine salt
myblu pod-system containing 16 mg nicotine salt tobacco flavour
干预措施: myblu 16 mg nicotine salt (Other)
myblu 25 mg nicotine salt
myblu pod-system containing 25 mg nicotine salt tobacco flavour
干预措施: myblu 25 mg nicotine salt (Other)
myblu 40 mg nicotine salt
myblu pod-system containing 40 mg nicotine salt tobacco flavour
干预措施: myblu 40 mg nicotine salt (Other)
结局指标
主要结局
Nicotine pharmacokinetics Cmax
时间窗: 30 minutes following the start of product use (12 measurements over the period)
Mean maximum plasma nicotine concentration (Cmax)
Nicotine pharmacokinetics Tmax
时间窗: 30 minutes following the start of product use (12 measurements over the period)
Median time to maximum plasma nicotine concentration (Tmax)
Nicotine pharmacokinetics AUC0-30
时间窗: 30 minutes following the start of product use (12 measurements over the period)
Mean area under the plasma nicotine concertation-time curve, from time zero to 30 minutes (AUC0-30)
次要结局
- Subjective effects questionnaire(20 minutes after the start of product use)
- Incidence and nature of any adverse events (AE)(Through study completion, 6 days)