Normal healthy volunteers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1,Japanese healthy adult men and women aged from 30 to 60 years old at the time of the screening 2,A person who is judged eligible for the study subject by the investigator or sub-investigator based on a result of the screening 3,Applicants who have been fully informed about the purpose and contents of this medical device and this study (including restrictions on subjects and others), and have given written consent to participate in the study on their own initiative
Exclusion criteria
Exclusion criteria: 1,A person who has a current disease 2,A person having medical history (such as diseases of the heart, liver, kidney, lung, blood) that is considered inappropriate for this study 3,A person who is currently participating in other clinical studies 4,A person who received a drug product in the participation in a Phase I clinical study within 16 weeks before this study, or in the participation in a clinical study within 12 weeks before this study 5,A person who is considered inappropriate by the investigators (examples: in case there are signs of peripheral circulatory insufficiency such as Raynaud phenomenon, or there is a rash requiring treatment, etc.) 6,A person who does not have the appropriate size in the prepared gloves and stockings, or that whose stocking size is SS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral skin temperature (hands and foot) 2 hours after compression using ECGS | — |
Secondary
| Measure | Time frame |
|---|---|
| Compression measurement Blood pressure in the lower legs SpO2 | — |
Countries
Japan
Contacts
Medical Corporation Hokubukai UTSUKUSHIGAOKA Hospital Clinical Pharmacology Center Pharmacology Center, interlocking head