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To quantitatively analyze the total radioactivity in the excreta of healthy male subjects after oral administration of [14C] SPH3127, and determine the cumulative excretion rate and main excretion routes of radioactive substances; to investigate the partition in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of [14C]SPH3127 in healthy male subjects; to identify the main metabolites in healthy male subjects after an oral administration of [14C] SPH3127, determine the main biotransformation pathways and main metabolites, quantitatively analyze the concentration of SPH3127 and main metabolites in plasma by validated LC-MS/MS method, and establish the pharmacokinetic parameters of SPH3127 and its main metabolites in plasma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH3127 | Experimental | Oral 100 mg [14 c] SPH3127 mixed suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH3127 | Drug | Oral 100 mg [14 c] SPH3127 mixed suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative excretion rate of total radioactive substances in excreta | Cumulative excretion rate of total radioactive substances in excreta(urine and faeces). | 240 hours |
| The concentration of SPH3127 in plasma | The concentration of SPH3127 in plasma was determined by liquid chromatography tandem mass spectrometry (LC-MS/MS). | Sampling performed at predose, and 10 minute,20 minute,0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24,48,72,96,120,144and 168 hours post-dose. |
| The total radioactivity in the collected plasma samples | The total radioactivity in the collected plasma samples was measured directly by liquid scintillation counter. | up to 168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Adverse event type, incidence, correlation with study drug | Predose and 240 hours post-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
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| ID | Term |
|---|---|
| C000709209 | SPH3127 |
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