Healthy Japanese
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women aged 20 or more and less than 65 at the time of agreement to participate in this study
Exclusion criteria
Exclusion criteria: 1. Individuals whose fasting blood glucose level is 126 mg/dL or more at screening (Scr) 2. Individuals whose hemoglobin A1c (HbA1c) is 6.5% or more at Scr 3. Individuals who take medicines that may influence the blood glucose level 4. Individuals who are currently taking "Foods for Specified Health Uses" or "Foods with Function Claims" 5. Individuals who are undergoing medical treatment or have a serious medical history of any disease such as liver, kidney, heart, lung, digestive organ, blood, endocrine system, or metabolic system 6. Individuals who have drug allergy or food allergy (such as eggs, milk ingredients, soybeans) 7. Individuals who are pregnant, planning to become pregnant during this study, or lactating 8. Individuals who are collected 400 mL or more of blood due to blood donation within 8 weeks before the agreement to participate in this study 9. Individuals who are dental decay or hypersensitive teeth 10. Individuals who are participating in other clinical trials or plan to participate in another study during this study 11. Individuals who are judged as ineligible to participate in this study based on the results of participant' background, physical finding, consultation, physical examination, and clinical examination, by principal physician or sub-physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incremental Area Under the Curve (IAUC)120 min of blood glucose level | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood glucose levels (blood glucose levels at each time point, the maximum blood concentration (Cmax), the time to maximum blood concentration (Tmax)) 2. Insulin (blood insulin levels at each time point, IAUC120 min, Cmax, Tmax) 3. Glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) (GIP, GLP-1 at each point, IAUC120 min, Cmax, Tmax) 4. Adverse events and side effects | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department