None listed
Conditions
Interventions
Oral administration for 4 weeks
Sponsors
ONE-INCH LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female Japanese subjects between 20 and 69 years old at the date of signing informed consent. 2.Healthy subjects with no therapy. 3.Subjects who can visit on schedule, and record their life diary every day. 4.Subjects who were fully informed of the objectives and contents, had a consent ability and voluntarily agreed to participate to the study in written consent.
Exclusion criteria
Exclusion criteria: 1.Subjects who have diabetes mellitus, liver disease, kidney disease, cardiovascular disease, or medical history. 2.Subjects who were judged as to be inappropriate by the data of laboratory test at the screening period. 3.Subjects who have any allergies. 4.Subjects who smoke more than 1 pack on average. 5.Subjects who regularly use pharmaceuticals, quasi-drugs, foods for specified health use foods with functional claims, supplements, health food, etc. 6.Subjects who drink more than 1,000mL of beer(5%) per day (40g of alcohol). 7.Subjects who are pregnant, breastfeeding, or plan to become pregnant or breastfeeding during the study period. 8.Subjects who participated or are planning to participate in other clinical trials within one month from the time of obtaining consent, or who are planning to participate 9.Subjects who are judged by the investigator to be inappropriate for participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective symptoms Blood pressure, Pulse rate Clinical laboratory test | — |
Secondary
| Measure | Time frame |
|---|---|
| POMS 2 STAI PMA-Impact (only in premenopausal women) Self-rating Depression Scale Pittsburgh Sleep Quality Index | — |
Countries
Japan
Contacts
Public ContactHiroki Yoshimura
APO PLUS STATION CO., LTD CRO Business division
Outcome results
None listed