Healthy subjects
Conditions
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females who are between 20 and 35 years of age at the time of written informed consent. 2.Subject with BMI <25.0kg/m2. 3.Non-smokers. (no smoking in the last year) 4.Subject who is fully explained the purpose and details of the study, has ability to consent, is volunteering to participate in the study with a full understanding of the explanation, and has consented to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1.Subject receiving medication or outpatient treatment for a serious disease. 2.Subject receiving exercise or diet therapy under the supervision of a physician. 3.Subject who has currently taking any products (e.g., foods for specified health use, foods with functional claims, dietary supplements or health foods, drugs, quasi-drugs) that can affect the autonomic nervous system, metabolism, or sleep, and are unable to discontinue taking them during the study period. 4.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past. 5.Subject with a history or current illnesses of serious diseases such as heart, liver, kidneys, digestive organs, brain, malignant tumors, immune diseases, diabetes, etc. 6.Subject who has problems with heart rate measurement (thick chest hair, using a pacemaker, rash on the skin (chest), etc.) 7.Heavy drinker. 8.Subject who has difficulty quitting drinking from the day before the test date. 9.Subject who has extremely irregular eating habits, those who have an extremely irregular rhythm of life, such a those who work in shifts or late at night. 10.Subject who is participating in other clinical trials at the time of obtaining consent, and who plans to participate in other clinical trials within 4 weeks from the end of the study to the start of the main study of the study, or after consenting to participate in the study. 11.Subject who has moved residences, changed jobs, separated from close relatives, or had equivalent events within the last 3 months and thus are likely to be under a great deal of stress, or who may have such an event during the study period. 12.Subject who exercises violently on a daily basis. 13.Subject who is aware of frequent urination 14.Subject with severe PMS (premenstrual syndrome) symptoms. 15.Women who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychological evaluation questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Heart rate sensor measurement data (Safety evaluation) Vital signs, physical measurements (body weight, BMI), adverse events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed