ISRCTN75583947进行中（未招募）未知
A randomized, open-label, crossover study to characterize nicotine pharmacokinetic parameters following the use of novel nicotine-containing products (Nordic Spirit) for oral use compared to Swedish portion snus and nicotine gum, in healthy adult snus users
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 30
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. Healthy male or female subject aged 19-64 years inclusive
- •3. Body Mass Index (BMI) =18.5 and =30.0 kg/m² at screening
- •4. Subject who currently use factory-made Swedish portion snus (nicotine content =8 mg per pouch) daily (=1 snus pouch per day, 7 days per week) and who indicate that they have used such snus continuously for at least six months prior to screening
- •5. Positive urine cotinine test (>200 ng/ml) at screening
- •6. Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator
- •7. Women of childbearing 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
排除标准
- •1. 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
- •2. Any clinically significant illness, medical/surgical procedure or trauma within 2 weeks of the first visit for the outcomes assessments
- •3. Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma
- •4. Any surgery within 6 months of the screening visit that could negatively impact on the subject's participation, as judged by the Investigator
- •5. Any planned major surgery within the duration of the study
- •6. Medical history of seizures (single occasions of febrile seizure in the childhood excluded)
- •7. Clinically significant liver disease, as judged by the Investigator, and/or an elevation in total bilirubin, alkaline phosphatase, LDH, AST, or ALT of >3 times the upper limit
- •8. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C virus antibodies and HIV
- •9. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to any use of the IP
- •10. Systolic blood pressure of =140 mmHg or diastolic blood pressure of =90 mmHg, after 10 min supine rest
- •11. Poor peripheral venous access, as judged by the Investigator
- •12. Female subjects who are pregnant or who are currently breastfeeding
- •13. History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator
- •14. Presence or history of drug abuse and/or anabolic steroids, as judged by the Investigator
- •15. Subjects who have used any tobacco/nicotine-containing products (including electronic cigarettes, heat-not-burn products, nicotine pouches etc) or NRT medications, other than factory-made Swedish portion snus within 14 days of screening. (A single occasional use of conventional cigarettes within the 14 days prior to screening is allowed)
- •16. Subjects who, prior to enrolment, are planning to quit tobacco use during the study period or are postponing a quit attempt in order to participate in the study. All subjects will be informed that they are free to quit tobacco use and withdraw from the study at any time
- •17. Any use of prescription or over-the-counter bronchodilator medication (e.g. inhaled or oral ß-adrenergic agonists) to treat a chronic condition within the 12 months prior to the first visit for the outcomes assessments
- •18. Any medication (prescription or over-the-counter [OTC]) within 14 days or within 5 half-lives of the drug (whichever was longer) prior to the first visit for the outcomes assessments, which has an impact on CYP2A6 activity
- •19. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening
- •20. Planned treatment or treatment with another investigational product within 3 months prior to the first visit for the outcomes assessments. Subjects consented and screened but not dosed in previous phase I studies are not excluded
- •21. Subjects who are employed by the tobacco industry, the clinical site, or handle u
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