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
ConditionsParkinson's disease
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.
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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