ISRCTN77807609已完成未知
icotine plasma concentrations and pharmacokinetics of single doses of non-tobacco-based nicotine pouches (ZYN®) compared with conventional, tobacco-based Swedish snus and American moist snuff among current, daily snus users
Swedish Match Europe Division0 个研究点目标入组 36 人开始时间: 2018年10月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32319528/ results (added 28/05/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Snus user who have used snus for =1 year, with a minimum weekly consumption of
- •two or more snus cans (brands with nicotine content =1%)
- •2. Willing and able to give written informed consent for participation in the study
- •3. Healthy
- •4. Aged 19 years or older
- •5. Willing and able to comply with study procedures
排除标准
- •1. Smoker, defined as smoking during the last 24 hours according to self-report and CO in exhaled air >10 ppm at clinical visits
- •2. A history or presence of diagnosed hypertension or any cardiovascular disease
- •3. 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
- •4. Any surgical or medical condition, which, in the judgement of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product
- •5. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
- •6. Breast feeding, pregnancy or planning to get pregnant during the study
- •7. Female use of systemic contraceptives (such as oral contraceptives, implants, injectable steroids, vaginal ring, transdermal patch)
- •8. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV)
- •9. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IP
- •10. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse
- •11. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening
- •12. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
研究者
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