Healthy subjects
Conditions
Interventions
Sponsors
others
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese male and female subjects between the ages of 20 and 65 at the time of written consent. 2) Subject who has received a full explanation of the purpose and content of the study, has the ability to consent, understand the study well, and has volunteered to participate in the study and has agreed to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1) Subject who is taking medication or under medical treatment. 2) Subject who is under exercise therapy or dietetic therapy. 3) Subject who is allergic to any food, pollen, or other allergens, regardless of the test food. 4) Subject with current or history of drug dependence or alcohol dependence. 5) Subject who is hospitalized for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea, etc.), or have a history of mental disorders in the past. 6) Subject with irregular life rhythms due to night shifts or shift work. 7) Subject with extremely irregular lifestyle habits such as eating and sleeping. 8) Subject who is or may be under the influence of alcohol to an excessive degree. 9) Subject who has an extremely unbalanced diet. 10) Serious diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease. (hepatitis), renal disease, heart disease, thyroid disease, adrenal disease, and other serious current or past diseases such as metabolic disease those who have. 11) Subject who has had abnormal or concerning liver function values (gamma-GTP, AST, ALT) indicated in previous health checkups, etc. 12) Subject who uses health foods, supplements, and medicines. 13) Subject who has participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period. 14) Subject who has collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition. 15) Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 16) Subject who has difficulty observing records on various survey forms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs, physical measurement, blood biochemistry, hematology, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactMasao Matsuoka
M&I Science CORP. Clinical Development Department
Outcome results
None listed