The Blood Kinetics MH001 after a Single Dose.
- Conditions
- o
- Registration Number
- JPRN-UMIN000049530
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 14
Not provided
[1] Individuals using medical products or used them in the past 1 month (except those for headaches or colds). [2] Individuals who are patient or have a history of psychiatric disease, sleep disorder, high blood pressure, diabetes and hyperlipidemia. [3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease and hematological disease. [4] Individuals who are a patient or have a history of or gastrointestinal disease. [5] Individuals with serious anemia [6] Individuals whose BMI is less than 18.5 kg/m2 and over 25.0 kg/m2. [7] Individuals who donated blood over 200 mL in the past 1 month or over 400 mL in the past 3 months. [8] Individuals who have and had a habit to ingest food with functional claims, health foods, or supplements in the past 1 month or will ingest those foods during the test period (from screening to the observation period II). [9] Individuals who experienced unpleasant feeling during blood drawing. [10] Individuals who are sensitive to the test food. [11] Smokers or individuals who have quit smoking for less than 6 months. [12] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). [13] Individuals who participated in other clinical studies in the past 1 month. [14] 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 of whole blood MH001
- Secondary Outcome Measures
Name Time Method [1] Blood kinetics of MH001 in plasma, whole blood and MH001 metabolites in plasma *Safety [1] Blood pressure, pulsation [2] Weight,body fat percentage,BMI [3] Doctor's questions / Adverse events *Other indexes [1] Baseline characteristics [2] height measurement [3] Hematologic test [4] Blood biochemical test [5] Urine analysis