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To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HMPL-306
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 µCi [14C] HMPL-306 | Experimental | After an overnight fasting of at least 10 hours, subjects will receive [14C] HMPL-306 containing 250 mg HMPL-306 (approximately 100 μCi radioactivity) 30 minutes after start of breakfast (must be completed within 30 minutes) and ensure that all of the drug is taken within 10 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 µCi [14C] HMPL-306 | Drug | D1: 250 mg/100 µCi [14C] HMPL-306 Single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Human Mass Balance | Recovery and cumulative recovery of total radioactivity in excreta (urine and feces). | Day1~Day29 |
| Human Mass Balance | Percentage of the unchanged drug and its metabolites in plasma to total radioactivity exposure levels in plasma; | Day-1~Day29 |
| Human Mass Balance | Percentage of the unchanged drug and its metabolites in urine and feces to the administered dose; | Day-1~Day29 |
| Human Mass Balance | Identification of major metabolites in plasma, urine and feces. | Day-1~Day29 |
| Human Mass Balance | PK parameters of total radioactivity in the plasma; Ratio of total radioactivity concentration in whole blood/plasma at different time points. | Day-1~Day29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao, offices director | The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) | Jinan | China |
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