ISRCTN88682435已完成不适用
An assessment of the biological uptake of nicotine among healthy adult smokers following a single controlled use of Heat Not Burn (HNB) 1.2 and a combustible cigarette
Japan Tobacco International0 个研究点目标入组 24 人开始时间: 2015年10月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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. Aged between 21 to 50 years of age
- •2. Good general health
- •3. Smoker for at least 12 months prior to check-in and currently smokes an average of 10 or more manufactured cigarettes per day (no restriction on brand-style, king size [~83 – 85 mm] and 100s [~98 – 100 mm] only)
- •4. Positive urine cotinine at screening (> 200 ng/mL) at screening
- •5. Female subjects must be non-pregnant and non-lactating
- •5. Pre-menopausal female subjects must be surgically sterile, use an investigator-approved method of birth control, or agree to be sexually abstinent from 14 days prior to check-in through the end of the study
排除标准
- •1. History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary (especially bronchospastic diseases), immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
- •2. Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results at Screening or Check-in, in the opinion of the Investigator
- •3. Positive test for HIV, HBsAg, or HCV
- •4. An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks prior to Check-in
- •5. Fever (>38?C) at Screening or at Check-in
- •6. Systolic blood pressure <90 mmHg or >150 mmHg, diastolic blood pressure <40 mmHg or >95 mmHg, or pulse rate <40 bpm or >99 bpm at screening
- •7. BMI <18 kg/m2 or >35 kg/m2 at screening
- •8. Use of prescription anti-diabetic medication and/or insulin therapy within 12 months of day 1 product administration.
- •9. Use of medications known to interact with CYP2A6 (including, but not limited to, amiodarone, desipramine, isoniazid, ketoconazole, miconazole, phenobarbital, rifampin, tranylcypromine, methoxsalen) within 3 months prior to day 1 product administration
- •10. Use of inhalers to treat any medical condition within 3 months prior to day 1 product administration and throughout the study
- •11. Positive urine screen for alcohol or drugs of abuse at screening or at check-in
- •12. History or presence of alcoholism or drug abuse within the past 2 years prior to screening
- •13. Drink alcohol in excess of 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit = 150 ml of wine or 360 mL of beer or 45 mL of 45% alcohol
- •14. Males who have donated blood within 12 weeks or females who have donated blood within 16 weeks prior to day 1 product administration.
- •15. Donation of bone marrow within the last 6 months prior to day 1 product administration
- •16. Participation in a previous clinical study for an investigational drug, biologic, medical device, or tobacco product within 90 days prior to day 1 product administration
- •17. Planning to quit smoking during the study period or postponing a quit attempt in order to participate in the study
- •18. Use of any prescription smoking cessation treatments, including, but not limited to, varenicline (Champix®) or buproprion (Zyban®) within 3 months prior to day 1 product administration and throughout the study
- •19. Known hypersensitivity to glycerol or propylene glycol
- •20. Subject or a first-degree relative is a current or former employee of the tobacco industry or a named party or class representative in litigation with the tobacco industry
研究者
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