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| Name | Class |
|---|---|
| Mochida Pharmaceutical Company, Ltd. | INDUSTRY |
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To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-FYU-981 | Experimental | 14C-FYU-981, (Oral single dosing) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-FYU-981 | Drug | 14C-FYU-981, (Oral single dosing) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax: Maximum plasma concentration) | 168 hours | |
| Pharmacokinetics (AUC: Area under the plasma concentration-time curve) | 168 hours | |
| Pharmacokinetics (Tmax: Time to reach the peak plasma concentration) | 168 hours | |
| Pharmacokinetics (T1/2: Elimination half-life of plasma concentration) | 168 hours | |
| Pharmacokinetics (kel: Elimination rate constant) | 168 hours | |
| Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed | 168 hours | |
| Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed) | 168 hours | |
| Pharmacokinetics (MRT: Mean residence time) | 168 hours | |
| Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air) | 168 hours or 72 hours (Ae(air)) | |
| Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air) | 168 hours or 72 hours (Ae(air)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| Pharmacokinetics (Ae(total): Total amount of radioactivity excreted) | 168 hours |
| Pharmacokinetics (fe(total): Total fraction of radioactivity excreted) | 168 hours |
| Pharmacokinetics (Ae(urine + air): Amount of radioactivity excreted in urine and air) | 168 hours |
| Pharmacokinetics (fe(urine + air): Fraction of radioactivity excreted in urine and air) | 168 hours |
| Pharmacokinetics (Ratios of FYU-981 and its metabolites in plasma, urine and feces) | 168 hours |