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Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]- Rongliflozin in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]- Rongliflozin | Experimental | Patients will receive single dose of [14C]- Rongliflozin (Suspension, 50mg/100μCi) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]- Rongliflozin | Drug | Patients will receive single dose of orally [14C]- Rongliflozin on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative excretion of 14C-labeled drug-related material (radioactivity in urine and fecal samples) | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine and feces. | up to 14 days |
| Identification of the Proportion of different metabolites to determine biotransformation pathway of Rongliflozin | Proportion of different metabolites(Rongliflozin and main metabolites). | up to 14 days |
| Distribution of radioactivity in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma | Radioactivity concentration in whole blood and plasma samples. | up to 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitive analysis of the concentrations of Rongliflozinand main metabolites in plasma using the validated liquid chromatography-tandem mass spectrometry(LC-MS/MS) to obtain pharmacokinetic data | The concentrations of Rongliflozin and main metabolites in plasma. | up to 11 days |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| liyan Miao, MD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
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Adverse events assessed by CTCAE v5.0. |
| up to 21 days |