ISRCTN44913332已完成未知
The in-vivo extraction of nicotine and flavor compounds from a single dose of a non-tobacco-based nicotine pouch (ZYN®) compared with conventional, tobacco-based Swedish snus among current, daily snus users
Swedish Match North Europe0 个研究点目标入组 20 人开始时间: 2017年11月21日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
2022 Results article in https://doi.org/10.3390/separations9020052 (added 15/02/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Snus user, with a minimum weekly consumption of three or more snus cans (brands with nicotine content <1%) or two or more cans (brands with nicotine content >1%) since =1 year
- •2. Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure
- •3. Healthy male/female, age =19. Female subjects should have a negative pregnancy test.
- •4. Willing and able to comply with study procedures
- •5. A heart rate increase = 10 beats/min with first use of snus in the morning after overnight abstinence from any nicotine exposure
排除标准
- •1. A history or presence of diagnosed hypertension or any cardiovascular disease
- •2. Surgery within 6 months of the screening visit that, in the opinion of the investigator, could negatively impact on the subject’s participation in the clinical study
- •3. Any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug
- •4. Subjects who are pregnant
研究者
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