Safety assessment study of continuous intake of plant extract containing food
Not Applicable
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000032394
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1) Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects who take anticholinergic drug, acetylcholinesterase inhibitor, or cholinergic agonist 3) Subjects who have the possibility of developing allergic symptoms by the test food 4) Subjects who are taking part in another clinical study when starting of the present study 5)Subjects having blood sample of over 200 ml within 1 month, or over 400 ml within 3 months prior to the start of the present study (e.g. donated blood) 6) Subjects deemed unsuitable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation index (blood test, urine test, physical examination, medical interview)
- Secondary Outcome Measures
Name Time Method