JRCT ID: jRCT1030210178
Registered date:01/07/2021
Study to Evaluate the Safety, Tolerability, and plasma hydroxyproline concentration of load of gelatin in the Healthy Adult Subjects
Basic Information
| Recruitment status | Complete |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy Adult Subjects |
| Date of first enrollment | 29/06/2021 |
| Target sample size | 12 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Ingestion of gelatin |
Outcome(s)
| Primary Outcome | Plasma hydroxyproline concentration Safety endpoints (Adverse events, Laboratory tests, Vital signs) |
|---|---|
| Secondary Outcome | none |
Key inclusion & exclusion criteria
| Age minimum | >= 20age old |
|---|---|
| Age maximum | <= 44age old |
| Gender | Male |
| Include criteria | Male BMI: 18.5 kg/m2 or more, less than 25.0 kg/m2 |
| Exclude criteria | Presence of a psychological, gastrointestinal, hepatic, renal, respiratory, endocrine, hematological, immune, neurological, cardiovascular disease or a congenital metabolic abnormality or other anomaly that may affect this study |
Related Information
| Primary Sponsor | Furihata Kenichi |
|---|---|
| Secondary Sponsor | EA Pharma co., Ltd. |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Yutaka Takeuchi |
| Address | 2-1-1, Irifune, Chuo-ku, Tokyo Tokyo Japan 104-0042 |
| Telephone | +81-3-6280-9600 |
| contact_ea@eapharma.co.jp | |
| Affiliation | EA Pharma Co., Ltd. |
| Scientific contact | |
| Name | Kenichi Furihata |
| Address | View Tower Hachioji 4F, 8-1, Yokamachi, Hachioji City, Tokyo Tokyo Japan 192-0071 |
| Telephone | +81-42-625-5216 |
| furihata@p1-clinic.or.jp | |
| Affiliation | P-One Clinic, Keikokai Medical Corporation |