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This is a phase I study evaluating HC-1119 single-dose pharmacokinetics and effect of food on its pharmacokinetics in healthy Chinese adults. The study primary objective is to evaluate the HC-1119 pharmacokinetic characteristics and the effect of food on its pharmacokinetics in healthy Chinese males, subsequent to a single oral administration of HC-1119 with different doses in healthy Chinese males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HC1119 | Experimental | Fasting state:40 mg, 80 mg, 160 mg; After meal: 160mg; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HC1119 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time 0 to infinity (∞) (AUC0-∞) | From the first dose of the study drug to day 50 | |
| Area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration(AUC0-t) | From the first dose of the study drug to day 50 | |
| Peak concentration (Cmax) | From the first dose of the study drug to day 50 | |
| Peak time (Tmax) | From the first dose of the study drug to day 50 | |
| Elimination half life (t1/2) | From the first dose of the study drug to day 50 | |
| Apparent clearance (CL/F) (prototype) | From the first dose of the study drug to day 50 | |
| Apparent volume of distribution (Vd/F) (prototype) | From the first dose of the study drug to day 50 | |
| Mean residence time (MRT) | From the first dose of the study drug to day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | Safety measures | From the first dose of the study drug to day 50 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital Ethics Committee | Shanghai | China |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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