JRCT ID: jRCT2031220536
Registered date:25/12/2022
Pharmacokinetic study of HP-6050
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Healthy adult and elderly |
Date of first enrollment | 12/01/2023 |
Target sample size | 60 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Healthy adult: Single dose of HP-6050 Healthy elderly: Single dose of HP-6050 |
Outcome(s)
Primary Outcome | Pharmacokinetic parameters, adverse events |
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Secondary Outcome | Pharmacodynamics |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | - Healthy Japanese adults aged >=18 and <65 years, or healthy Japanese elderly aged >=65 years (at the time of informed consent) |
Exclude criteria | - Subjects with current or history of serious cardiac, vascular, renal, hepatic, psychiatric/neurological, or metabolic diseases - Subjects who received any drug within a week prior to application of the study drug |
Related Information
Primary Sponsor | Inakura Hiroshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Contact for Clinical Trial Information Clinical Development Department |
Address | 2-4-1 Marunouchi, Chiyoda-ku, Tokyo Tokyo Japan 100-6330 |
Telephone | +81-3-5293-1734 |
shikenjoho@hisamitsu.co.jp | |
Affiliation | Hisamitsu Pharmaceutical Co., Inc. |
Scientific contact | |
Name | Hiroshi Inakura |
Address | 2-4-1 Marunouchi, Chiyoda-ku, Tokyo Tokyo Japan 100-6330 |
Telephone | +81-3-5293-1734 |
shikenjoho@hisamitsu.co.jp | |
Affiliation | Hisamitsu Pharmaceutical Co., Inc. |