Pharmacokinetic test by single ingestion of the test food
- Conditions
- o
- Registration Number
- JPRN-UMIN000051122
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1) Individuals using medical products. 2) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. 3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. 4) Individuals who are a patient or have a history of or endocrine disease. 5) Individuals with serious anemia. 6) Individuals who used a drug to treat a disease in the past 1 month. 7) Individuals whose BMI is less than 18.5kg/m2 and over 25.0kg/m2. 8) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. 9) Individuals who have and had a habit in the past 1 month to ingest food with functional claims, health foods, or supplements. 10) Individuals who experienced unpleasant feeling during blood drawing. 11) Individuals with drug and food allergies. 12) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). 13) Individuals who are or are possibly pregnant, or are lactating. 14) Individuals who participated in other clinical studies in the past 1 month. 15) Individuals judged inappropriate for the study by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood kinetics (Blood hesperetin concentration, AUC(0-7h),iAUC(0-7h), Cmax, Tmax)
- Secondary Outcome Measures
Name Time Method *Secondary indexes [1] Blood kinetics (AUC(0-inf),T1/2,MRT,Kel) *Safety [1] Doctor's questions. [2] Adverse events *Other indexes [1] Baseline characteristics [2] height measurement [3] Blood pressure, pulsation. [4] Weight, body fat percentage, BMI [5] Infectious disease-related tests