JPRN-jRCT2080222651未知1 期
A Phase 1 study on single and multiple oral dose administration of ONO-2160/CD in healthy adult male subjects and on multiple oral dose administration of ONO-2160/CD in Parkinson's disease patients
ONO PHARMACEUTICAL CO.,LTD.0 个研究点目标入组 34 人开始时间: 2014年11月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 34
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
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •Healthy adult part
- •1. BMI: >= 18. 5, < 25. 0
- •Age : 20 to 45 years
- •Parkinson's disease patient part
- •1. Patients who have been diagnosed with Parkinson's Disease according to the clinical diagnosis criteria of UK Parkinson's Disease Society Brain Bank
- •2. Patients whose Mini Mental State Examination score >= 24 at screening
- •Age : 20 to 74 years
- •Sex : male and female
排除标准
- •Healthy adult part
- •1. A volunteer who has developed acute gastrointestinal symptoms (e.g. diarrhea, nausea, heart burn) within 7 days in prior to the study drug administration, or a volunteer who is observed with these gastrointestinal symptoms on a daily basis.
- •Parkinson's disease patient part
- •1. A patient whose medical history, physical findings, laboratory test results can suggest parkinsonism from other causes than Parkinson's Disease
- •2. A patient who has received surgical treatments for Parkinson's Disease such as stereotactic neurosurgery, or who is planned with surgical treatments during the study period
研究者
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