JPRN-UMIN000024988已完成未知
A randomised, controlled, multi-centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional combustible cigarette to the glo tobacco heating product. - A study to examine changes in exposure to cigarette smoke chemicals when a smoker switches to using a tobacco heating product.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 180
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
- 年龄范围
- 23years-old 至 55years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a barrier method of contraception in addition to a second highly effective method of contraception used by their female partners or to refrain from donating sperm from Admission until the end of the safety Follow-up period. 2. Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception from the time of signing the ICF until the end of the safety Follow-up period. 3. Female subjects who are pregnant or breastfeeding. 4. Subjects who have an acute illness requiring treatment within 4 weeks prior to Admission. 5. Subjects who have regularly used any nicotine or tobacco product other than commercially manufactured filter cigarettes within 14 days of Screening. 6. Subjects who are self-reported non-inhalers. 7. Subjects who, prior to enrolment, are planning to quit smoking in the next 12 months. 8. Subjects who have serum hepatitis; are carriers of HBsAg; are carriers of the hepatitis C antibody; have a positive result for the test for HIV antibodies; or have syphilis. 9. Subjects who have used prescription or OTC bronchodilator medication to treat a chronic condition within the 12 months prior to Admission. 10. Subjects who have any clinically relevant abnormal findings on the physical examination, medical history, ECG, lung function tests or clinical laboratory panel. 11. Subjects who have, or who have a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the PI, would jeopardise the safety of the subject or impact on the validity of the study results. 12. Subjects who have previously been diagnosed with any form of malignancy.
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