Safety assessment study on excessive intake of test supplement
Not Applicable
- Conditions
- Healthy volunteer
- Registration Number
- JPRN-UMIN000030679
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
1.Subjects who have a history or present serious disease such hepatic disorder, cardiovascular disorder, respiratory disorder, endocrine disorder, metabolic disorder. 2.Subjects who have a disease requiring regular medication. 3.Subjects who are at risk of developing allergy in relation to the test supplement 4.Subjects who are participating in other clinical trials when start of the examination period 5.Subjects who intend to become pregnant or lactating 6.Subjects who donated 200 mL in the past month or more than 400 mL within 3 months (blood donation etc.) 7.Subjects who are judged as unsuitable for the study by the principal doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment on ingestion of test supplement, 5-fold quantity of recommended daily intake, for consecutive 4 weeks.
- Secondary Outcome Measures
Name Time Method