icotine plasma concentrations and pharmacokinetics of single doses of non-tobacco-based nicotine pouches (ZYN Moist and ZYN Dry Mini) and conventional, tobacco-based US moist snuff pouches among current, daily snus users

Swedish Match0 个研究点目标入组 35 人开始时间: 2020年7月28日最近更新: 2024年1月8日

试验速览

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•1. Willing and able to give written informed consent for participation in the study
•2. Snus user who has used tobacco-based snus for =1 year, with a minimum weekly consumption of two or more snus cans, and is willing and able to usebrandsuse brands with nicotine content =1%
•3. Healthy male or female subject aged =19 years
•4. Women of childbearing potential (WOCBP) must be willing to use a sufficient contaceptive method for the duration of the study, this includes mechanical barrier (e.g., a male condom or a female diaphragm), combined [oestrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen-only hormonal anticonception associated with inhibition of ovulation [oral, injectable, implantable], IUD or IUS. Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject

•1. Daily smoker, defined as smoking during the last 24 hours according to self-report
•2. A history or presence of diagnosed hypertension or any cardiovascular disease
•3. Any surgical or medical condition, or history thereof, which, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product or may either put the subject at risk because of participation in the study, influence the results, or the subject’s ability to participate in the study
•4. Female subject currently breastfeeding, pregnant or planning to get pregnant during the study
•5. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV)
•6. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to first administration of the IP
•7. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse, as judged by the investigator
•8. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening
•9. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements

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