Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to healthy subjects
Not Applicable
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000022825
- Lead Sponsor
- Hiroshima University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Not provided
Exclusion Criteria
1) Taking medicines for chronic disease 2) Taking functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) In pregnancy or nursing a child 5) History of severe disease and/or major surgery 6) History of hypersensitivity caused by 5-aminolevulinic acid or porphyrin 7) Subject or family history of diagnosis of porphyria 8) Severe anemia (Hemoglobin < 10 g/dL) 9) Judged as ineligible by clinical investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event including laboratory abnormality and the change of CTCAE grade
- Secondary Outcome Measures
Name Time Method