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This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR3824 10mg fasted to fed | Experimental | SHR3824 tablet, fasting conditions day 1, visit 2, 7 days wash-out, SHR3824 tablet, high fat, high calorie breakfast day 1, visit 3. |
|
| SHR3824 10mg fed to fasted | Experimental | SHR3824, high fat, high calorie breakfast day 1, visit 2, 7 days wash-out, SHR3824, fasting conditions day 1, visit 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3824 | Drug | SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) of SHR3824 | Cmax (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state | Day 1-4 on visit 2 and visit 3 |
| The area under the plasma concentration-time curve (AUC) of SHR3824 | AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state | Day 1-4 on visit 2 and visit 3 |
| The accumulative excretion rate of SHR3824 and its metabolites in urine and feces | Accumulative excretion rate will be compared under fating state and fasted state | Day 1-4 on visit 2 and visit 3 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability. | Up to Day 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D054119 | Arachnodactyly |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000611095 | henagliflozin |
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| D004700 | Endocrine System Diseases |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |