NL-OMON50057已完成不适用
Open-Label, Mass Balance Study to Investigate the Absorption, Distribution, Metabolism And Excretion Of [14C]-Etripamil Nasal Spray After a Single Dose to Healthy Male Subjects. - CS0342 Milestone Pharmaceuticals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
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
- 18 至 99（—）
入选标准
- •Able to provide informed consent to participate in this study after reading the
- •participant information sheet and informed consent form and after having the
- •opportunity to discuss the study with the Investigator or designee.
- •Healthy and free from clinically significant illness or disease as determined
- •by medical history, physical examination, laboratory and other tests at
- •Caucasian male subjects, aged 18 to 65 years (inclusive) at Screening.
- •A body weight of >=60 kg and a body mass index ranging from 18.0 to 30.0 kg/m2
- •at Screening.
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate
- •and ECG) deviating from normal and of clinical relevance.
- •History or current clinically significant cardiovascular, gastrointestinal,
- •hepatic, renal, respiratory, metabolic, immunologic, hormonal disorders.
- •History of atrioventricular block, myocardial infarction (MI) or angina,
- •non-sustained or sustained ventricular tachycardia (VT), family history of
- •sudden death or prolonged QT interval, vaso-vagal syncope, sick sinus syndrome,
- •supraventricular tachycardia, atrial flutter, Atrial fibrillation (AFib),
- •stroke, transient ischemic attack (TIA), unexplained syncope, congestive heart
- •failure (CHF), or Torsade de Pointes.
研究者
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