ACTRN12612000821897已完成1 期
A single centre, double blind, randomised, placebo controlled, parallel group, ascending single dose, safety and tolerability, pharmacokinetic and pharmacodynamic study of oral noribogaine in healthy participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- DemeRx, Inc.
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •a) Provide written informed consent
- •b) Male or surgically sterilized female.
- •c) Body Mass Index greater than or equal to 18.5 and less than 30kg/m2 on the day of consent.
- •d) Healthy individuals as determined by medical history, physical examination, ECG, vital signs and laboratory tests.
排除标准
- •a) Evidence from medical history, physical or laboratory examinations of significant neurologic, psychiatric, cardiac, respiratory, renal, hepatic, endocrine, gastrointestinal, immunological condition or any other diagnosed conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug, interfere with the ability to accurately record study measurements (e.g., cataracts) or which may potentiate or predispose to undesired effects.
- •b) Any history of seizure or convulsion, including febrile convulsion in childhood.
- •c) A history of alcohol or drug abuse or dependency
- •d) History of mental illness requiring medication or treatment by a physician.
- •e) Any participant for whom the investigator believes, for any reason, inclusion would not be an acceptable risk.
研究者
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