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临床试验/JPRN-jRCT2080222143
JPRN-jRCT2080222143未知1 期

A Phase 1 study on single oral dose administration of ONO-2160/CD in healthy adult male subjects and Parkinson's disease patients

ONO PHARMACEUTICAL CO.,LTD.0 个研究点目标入组 42 人开始时间: 2013年7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
42

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 who have been administered levodopa/carbidopa hydrate combination tablets without prescription change within 28 days in prior to the study drug administration in the Period 1
  • 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

发起方
ONO PHARMACEUTICAL CO.,LTD.

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