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The purpose of this study is to assess the pharmacokinetics, safety and pharmacodynamics after single oral administration of FYU-981 to male and female elder subjects in comparison with non-elder subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male elder subjects | Experimental | Male 65- Years |
|
| Male non-elder subjects | Experimental | Male 20-35 Years |
|
| Female elder subjects | Experimental | Female 65- Years |
|
| Female non-elder subjects | Experimental | Female 20-35 Years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYU-981, (Oral single dosing) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax: Maximum plasma concentration) | 48 hours | |
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) | 48 hours | |
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 48 hours | |
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 48 hours | |
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) | 48 hours | |
| Pharmacokinetics (kel: Elimination rate constant) | 48 hours | |
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed | 48 hours | |
| Pharmacokinetics (MRT: Mean residence time) | 48 hours | |
| Pharmacokinetics (Ae: Amount of drug excreted in urine) | 48 hours | |
| Pharmacokinetics (fe: Fraction of dose excreted in urine) | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31889230 | Derived | Nakatani H, Fushimi M, Sasaki T, Okui D, Ohashi T. Clinical pharmacological study of dotinurad administered to male and female elderly or young subjects. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):8-16. doi: 10.1007/s10157-019-01836-0. Epub 2019 Dec 30. |
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| ID | Term |
|---|---|
| C000706811 | dotinurad |
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