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| Name | Class |
|---|---|
| Fuji Yakuhin Co., Ltd. | INDUSTRY |
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This is a randomized, open-label, 2-period crossover study. The purpose of this study is to assess the pharmacokinetics and safety after single oral administration of final formulation of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics of FYU-981 is also investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasted dosing followed by fed dosing | Experimental | Dosing of FYU-981 in the fasted state followed by fed dosing |
|
| Fed dosing followed by fasted dosing | Experimental | Dosing of FYU-981 in the fed state followed by fasted dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FYU-981 | Drug | Single administration of FYU-981 under Fasted and fed conditions in the morning. |
|
| 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 | |
| Safety (Incidence of treatment-emergent adverse events) | 13 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katsuaki Nagasawa | Clinical Research Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P-One Clinic | Hachiōji | Tokyo | 192-0071 | Japan |
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| ID | Term |
|---|---|
| C000706811 | dotinurad |
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