ISRCTN91637022已完成未知
icotine plasma concentrations, pharmacokinetics, and pharmacodynamics following single doses of flavored oral tobacco-derived nicotine pouches in current, daily oral tobacco/nicotine users
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Willing and able to give written informed consent for participation in the study
- •2. Subjects who have used oral tobacco/nicotine products for =1 year, with a minimum daily consumption of five or more pouches, and who are willing and able to use products with nicotine content =1 %
- •3. Healthy male or female subject aged =21 years
- •4. Clinically normal medical history, physical findings, vital signs, ECG, and laboratory values at the time of screening, as judged by the Investigator
- •5. Female subjects of child-bearing potential 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 [estrogen 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], intrauterine device (IUD) or intrauterine system (IUS). Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject
排除标准
- •1. A history of diagnosed hypertension or any cardiovascular disease, or ongoing manifestations of hypertension or any cardiovascular disease as judged by the Investigator
- •2. 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, distribution, metabolism or excretion 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
- •3. Subjects who are pregnant, breastfeeding, or intend to become pregnant during the course of the study
- •4. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV)
- •5. A history of diagnosed severe allergy/hypersensitivity or ongoing manifestations of severe allergy/hypersensitivity to aroma compounds (including fragrances and/or flavorings), as judged by the Investigator
- •6. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to first IP administration. Positive results that are expected given the subject’s medical history and prescribed medications can be disregarded as judged by the Investigator
- •7. Current, ongoing use of beta-adrenergic blocking agents (beta-blockers), including pro re nata (as needed) use
- •8. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse, as judged by the Investigator
- •9. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the 3 months prior to screening
- •10. Subjects who intend to change their nicotine consumption habit, including the intention to stop using nicotine products, within the next 3 months from the screening visit, as judged by the Investigator
- •11. The Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements
研究者
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