ISRCTN13589495已完成Unknown
icotine plasma concentrations, pharmacokinetics, and pharmacodynamics following single doses of nicotine pouches with a new format in current, daily oral tobacco/nicotine pouch users
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 38
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 who are willing and able to use both tobacco-based moist snuff and NPs with high nicotine content
- •3. Healthy male or female subjects aged 21 to 60 years, inclusive
- •4. Medically healthy subject without abnormal clinically significant medical history, physical findings, vital signs, ECG, and hepatitis B/C and human immunodeficiency virus (HIV) results at the time of the screening visit, as judged by the Investigator
- •5. Successful completion of the product familiarization session for the comparator product use is required before the first IP administration. The subject should be able to follow the instructions, tolerate the product, and not experience any adverse effects different from what is expected during typical smokeless pouch use in the training session.
- •6. Female subjects of childbearing potential must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of <1% to prevent pregnancy for the duration of the study. The following are considered highly effective methods of contraception:
- •6.1. Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- •6.2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- •6.3. Intrauterine device or intrauterine hormone-releasing system
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. 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
- •4. Subjects with poor venous access or being scared of needles
- •5. Any planned major surgery within the duration of the study
- •6. Subjects who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the study
- •7. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or HIV
- •8. Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the study site prior to IP administration. Positive results that are expected given the subject’s medical history and prescribed medications can be disregarded as judged by the Investigator
- •9. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator
- •10. Presence or history of drug abuse, as judged by the Investigator
- •11. History of, or current use of anabolic steroids, as judged by the Investigator
- •12. Current, ongoing use of beta-adrenergic blocking agents (beta blockers), including pro re nata (as needed) use
- •13. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening
- •14. Subjects who intend to change their nicotine consumption habit, including the intention to stop using nicotine products, within the next 3 months of the screening visit, as judged by the Investigator
- •15. The Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements
研究者
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