Healthy volunteers
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese men and women aged 30 to 64 at the time of obtaining informed consent to participate in the study. 2)Participants who have received a full explanation of the purpose and procedures of the study and have provided written informed consent prior to study initiation.
Exclusion criteria
Exclusion criteria: 1)Participants currently undergoing treatment for, or with a history of, malignant tumors, heart failure, or myocardial infarction. 2)Participants with an implanted pacemaker or implantable cardioverter-defibrillator (ICD). 3)Participants currently undergoing treatment for the following chronic conditions: arrhythmia, liver disease, kidney disease, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, osteoporosis, or other chronic conditions. 4)Participants with a history of jaw or facial bone surgery. 5)Participants wearing dental implants, removable dentures, or orthodontic appliances. 6)Participants experiencing significant pain, bleeding, or pus discharge in the oral cavity due to severe dental caries, periodontitis, or similar conditions. 7)Participants regularly consuming health foods (such as foods for specified health uses, foods with nutritional functions, foods with functional claims, and supplements) that may affect bone density (bone metabolism or bone formation). 8)Participants who have undergone a barium examination within 2 weeks prior to the trial date. 9)Participants who are pregnant, breastfeeding, or intend to become pregnant during the trial period. 10)Participants currently participating in a clinical trial, or who have participated in another clinical trial within the past 3 months from the date of informed consent. 11)Other participants who are judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone density of the facial bones | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone density measured by the DEXA method | — |
Countries
Japan
Contacts
APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.