Healthy adult volunteers
Conditions
Interventions
Single ingestion of 5 tablets of food containing flavonoids
Single ingestion of 5 tablets of placebo
Sponsors
Morishita Jintan Co.,Ltd.
International Institute for Integrative Sleep Medicine, University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females whose age are 20<= years old when the consent is obtained. (2) Subjects who receive an explanation about this trial in advance, understand the content, agree with the purpose, and obtain the written consent.
Exclusion criteria
Exclusion criteria: (1) Subjects whose systolic blood pressure is under 90 mmHg. (2) Subjects who fall under any of the following items; A) Subjects with heart, liver, or kidney disease (including complications of other diseases) B) Subjects with a history of cardiovascular disease C) Subjects with diabetes D) subjects with a history of gastrointestinal surgery (gastrectomy, gastrointestinal suture, intestinal resection, etc.) that may affect drug absorption E) Subjects with or suspected gastrointestinal obstruction and gastrointestinal motility F) Subjects with abnormal vomiting reflex G) Subjects with test food or drug allergies (including allergies to alcohol used to disinfect the puncture site) H) Subjects who donated 400 mL or more within 90 days, 200 mL or more within 60 days, or those who donated component blood within 30 days I) Pregnant or potentially pregnant women, and lactating women (3) Subjects who ingested rose hips, strawberries, linden, grapefruit, foods containing St. Jones wort and dietary supplements (including supplements and beverages) within 3 days before the start of this study. (4) Subjects who drink habitually (drinking 40 g of pure alcohol or more twice a week) or who drank within 2 days before the start of this study. (5) Subjects who have a smoking habit and those who smoked within 2 days after the start of this study. (6) Subjects who show a positive reaction with HBs antigen, HCV antibody, syphilis serum reaction and HIV antigen / antibody. (7) Subjects with a lean type (BMI less than 18.5). (8) Subjects who are judged to be unsuitable for the test by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-dependent change of blood flavonoids from administration to 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| The area under the curve (AUC0-24) | — |
Countries
Japan
Contacts
Public ContactAkifumi Nagatomo
Morishita Jintan Co.,Ltd. Health Care Product Department
Outcome results
None listed