Safety assessment study on excessive intake of test supplement -A randomized, double blind, placebo controlled, parallel study
- Conditions
- Healthy volunteer
- Registration Number
- JPRN-UMIN000033201
- Lead Sponsor
- FANCL Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1.Subjects who have judged to have problems with participation in examination due to clinical laboratory test values or cardiorespiratory abnormality 2.Subjects who are at risk of developing allergy in relation to the test supplement. 3.Subjects who have a disease requiring regular medication. Subjects who have a history of serious illness requiring medication treatment 4.Subjects whose clinical laboratory values and measured values before ingestion are significantly out of the reference range 5.Subjects who are participating in other clinical trials when start of the examination period 6.Subjects who intend to become pregnant or lactating 7.Subjects who are judged as unsuitable for the study by background survey results 8.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