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This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]ZSP1273 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of ZSP1273.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]ZSP1273 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] ZSP1273 | Drug | 600 mg suspension containing 50μCi of [14C]ZSP1273 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity in plasma PK: Cmax | Up to 14 days from the start of administration. | |
| Total radioactivity in plasma PK: AUC0-t | Up to 14 days from the start of administration. | |
| Total radioactivity in plasma PK: CL/F | Up to 14 days from the start of administration. | |
| Total radioactivity in plasma PK: Vz/F | Up to 14 days from the start of administration. | |
| Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae) | Up to 14 days from the start of administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | Up to 23 days (approx) from the start of administration. | |
| Quantitive analysis of the concentrations of ZSP1273 and its major metabolites(if applicable) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First affiliated hospital of Suzhou university | Suzhou | China |
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| ID | Term |
|---|---|
| C000721066 | ZSP1273 |
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| Up to 14 days from the start of administration. |