ISRCTN14866695已完成未知
icotine pharmacokinetics and subjective effects of 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 18 人开始时间: 2017年11月21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
- 18
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, 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
- •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. 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 judgment 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. Pregnancy or planning to get pregnant during the study
- •7. Positive screen for drugs of abuse at screening or on admission to the unit prior to administration of the investigational product.
- •8. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV)
- •9. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse
- •10. Use of any prescribed or non-prescribed medication including antacids, analgesics and herbal remedies within two weeks prior to the first administration of IP, except occasional intake of paracetamol (maximum 2 000 mg/day; and not exceeding 3 000 mg/week), at the discretion of the Investigator
- •11. Plasma donation within 1 month of Screening or any blood donation/blood loss >450 mL during the 3 months prior to Screening
- •12. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
研究者
相似试验
已完成
不适用
A study investigating the uptake to the blood circulation of nicotine from tobacco free nicotine pods compared to tobacco-based Swedish snus and American moist snuffTobacco useISRCTN77807609Swedish Match Europe Division36
进行中（未招募）
不适用
icotine plasma concentrations and subjective effects of a single dose of Nicachet 4 mg nicotine oromucosal powder in pouch compared with 4mg Nicorette chewing gum and 1mg Nicorette nasal spray. - Nicotine oromucosal powder in pouchSmoking cessationEUCTR2010-024445-78-SEMagle AB20
已完成
不适用
A study investigating the uptake to the blood circulation of nicotine from tobacco-free nicotine pouches compared to American moist snuff pouchesISRCTN13527565Swedish Match35
已完成
不适用
A study investigating the uptake to the blood circulation and subjective effects of nicotine from tobacco-free nicotine pouchesicotine useISRCTN66329631Swedish Match44
已完成
Unknown
Plasma nicotine concentrations following single doses of new-format nicotine pouchesicotine useISRCTN13589495Swedish Match North Europe AB38