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| Name | Class |
|---|---|
| Shanghai Haini Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
This study is a single-center, single-dose, non-randomized, open-label design with two parts. Each subject will receive a single oral dose of [14C]DWP14012 suspension (containing approximately 40 mg/80 μCi [14C]DWP14012) under the fasting conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]DWP14012 | Experimental | Type: [14C]DWP14012 suspension containing 40 mg/80 μCi Dosage: orally take the suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]DWP14012 | Drug | Each subject will receive a single oral dose of [14C]DWP14012 suspension (containing approximately 40 mg/80 μCi [14C]DWP14012) under fasting conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to peak Concentration | Up to 168hours(approx) from administration |
| Cmax | Maximum Concentration | Up to 168hours(approx) from administration |
| AUC0-t | Area under the plasma concentraion-time curve | Up to 168hours(approx) from administration |
| AUC0-∞ | Area under the curve from time 0 extrapolated to infinite time | Up to 168hours(approx) from administration |
| t1/2 | Elimination Phase Half-life | Up to 168hours(approx) from administration |
| MRT | Mean Residence Time | Up to 168hours(approx) from administration |
| CL/F | apparent oral clearnace | Up to 168hours(approx) from administration |
| Vd/F | apparent oral volume of distribution | Up to 168hours(approx) from administration |
| Ratio of total radioactivity in whole blood/plasma |
| Measure | Description | Time Frame |
|---|---|---|
| To observe the safety of [14C]DWP14012 | Adverse events, serious adverse events etc. | Up to study completion, approximately up to 2000 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fang Hou | Beijing GoBroad Boren Hospital | Principal Investigator |
| Wel Tan | Beijing GoBroad Boren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Boren Hospital | Beijing | China |
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A single-center, single-dose, open-label design
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Total measured radioactivity content of urine and fecal samples collected at each sampling interval
| Up to 168hours(approx) from administration |
| Cumulative recovery of total radioactive substances | Measurement of cumulative recovery ratio in urine or/and feces to meet the criteria for termination | Up to 168hours(approx) from administration |