In vivo extraction of nicotine and flavor compounds from a single dose of non-tobaccobased nicotine pouches (ZYN Moist)

Swedish Match0 个研究点目标入组 35 人开始时间: 2021年2月9日最近更新: 2024年1月8日

适应症

试验速览

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•1. Willing and able to give written informed consent for participation in the study
•2. Male or female subject aged =19 years
•3. Subject who has used oral tobacco/nicotine products for =1 year, with a minimum daily consumption of five or more snus pouches, and is willing and able to use brands with nicotine content =1%
•4. Women of child bearing potential (WOCBP) must be willing to use a sufficient contraceptive 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. Any surgical or medical condition including abnormal salivation (also pharmaceutically induced), or history thereof, which, in the judgment of the Investigator, might interfere with the absorption of the IP 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
•2. Any clinically significant illness in the 28 days prior to the first IP administration
•3. A history or presence of untreated diagnosed hypertension or any cardiovascular disease
•4. Female subject currently breast feeding, pregnant or planning to get pregnant during the study
•5. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to first administration of the IP
•6. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse, as judged by the Investigator
•7. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements

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