None listed
Conditions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1] Japanese males aged 20-34 years [2] Individuals whose written informed consent has been obtained after explanation of this study.
Exclusion criteria
Exclusion criteria: [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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood kinetics of whole blood MH001 | — |
Secondary
| Measure | Time frame |
|---|---|
| [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 | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed