Healthy Volunteer
Conditions
Interventions
Single oral administration of ONR-13
Single oral administration of Placebo
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who are voluntarily giving written informed consent. 2) Healthy volunteers aged between 20 and 49. 3) Healthy volunteers BMI between 18.5 and 29.9. 4) Fasting blood glucose less than 126mg/dL. 5) 120-minute blood glucose value less than 200 mg/dl during an OGTT (oral glucose tolerance test) with a 75 g glucose load.
Exclusion criteria
Exclusion criteria: (1) Subjects who cause allergic symptoms in foods and medicines. (2) Subjects who contract or are under treatment for diseases (e.g., liver disease, kidney disease, heart disease, respiratory disease, digestive disease and/or metabolic disease). (3) Subjects who have donated over 400 mL of blood within the last three months, over 200 mL of blood within the last one month or over blood components within the last two weeks prior to the current study. (4) Subjects with systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more at screening test. (5) Subjects whose systolic blood pressure is less than 90 mmHg. (6) Subjects who are pregnant or planning to become pregnant after informed consent and who wish to become pregnant during this study or who cannot consent appropriate contraception. (7) Subjects who are lactating. (8) Subjects who are not negative for syphilis, HBs antigen, HCV antibody or HIV antigen/antibody test. (9) Alcoholic drinkers (more than 40 grams of pure alcohol per day) and subjects who smoke more than 20 cigarettes a day. (10) Subjects who are shiftworker and/or midnight-shift worker. (11) Subjects who can't stop using, medicin, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during test periods. (12) Subjects who are under treatment for or have a history of drug addiction. (13) Subjects who are planning to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month prior to the current study. (14) Subject who can't keep the daily records. (15) Subjects who are judged unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial circulating peptide hormone level | — |
Secondary
| Measure | Time frame |
|---|---|
| Postprandial blood glucose level | — |
Countries
Japan
Contacts
Public ContactHiroki Noguchi
Otsuka Pharmaceutical Co., Ltd. Otsu Nutraceuticals Research Institute
Outcome results
None listed