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To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects following multiple oral doses of HMPL-523 tablets followed by a single oral dose of [14C]HMPL-523 suspension
a single-center, non-randomized, open-label, human mass balance, phase 1 study to evaluate the absorption, metabolism and excretion following multiple oral doses of HMPL-523 tablets, followed by a single oral dose of 300 mg/150 µCi [14C]HMPL-523 suspension in healthy adult male Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMPL-523 | Experimental | HMPL-523 Tablet 300 mg QD7 days followed by a single oral dose of [14C]HMPL-523 suspension |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMPL-523 | Drug | D1-D7: HMPL-523 Tablet 300 mg QD |
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| Measure | Description | Time Frame |
|---|---|---|
| the Human Mass Balance | To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects following multiple oral doses of HMPL-523 tablets | Day1-Day7 |
| the Human Mass Balance | To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects followed by a single oral dose of [14C]HMPL-523 suspension | Day8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao | offices director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
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| 150 µCi [14C]HMPL-523 | Drug | D8: [14C] HMPL-523 Suspension 300 mg/150 μCi Single dose |
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