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Clinical Trials/JPRN-jRCT2080222143
JPRN-jRCT2080222143
Unknown
Phase 1

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 sites42 target enrollmentJuly 12, 2013

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Parkinson's disease
Sponsor
ONO PHARMACEUTICAL CO.,LTD.
Enrollment
42
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 12, 2013
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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