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The purpose of this study is to assess the effect of food on the single-dose PK of SHR3824, SP2086 and metformin in the HR20031 FDC tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR20031 FDC 10/100/1000 mg in the fast state | Experimental |
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| HR20031 FDC 10/100/1000 mg in the fed state | Experimental |
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| HR20031 FDC 5/50/750 mg*2 in the fast state | Experimental |
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| HR20031 FDC 5/50/750 mg*2 in the fed state | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR20031 FDC | Drug | Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fast state followed by 7 days washout ,then receive treatment HR20031 FDC 10/100/1000 mg in the fed state . |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of SHR3824 in the fast and fed state: Cmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of SP2086 in the fast and fed state: Cmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of Metformin in the fast and fed state: Cmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of SHR3824 in the fast and fed state: AUC0-t | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of SP2086 in the fast and fed state: AUC0-t | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of Metformin in the fast and fed state: AUC0-t | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of SHR3824 in the fast and fed state: AUC0-inf (if applicable) | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of SP2086 in the fast and fed state: AUC0-inf (if applicable) | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of Metformin in the fast and fed state: AUC0-inf (if applicable) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of SP2086A in the fast and fed state: Cmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of SP2086A in the fast and fed state: AUC0-t | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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There will be two independent cohorts of subjects who will each receive two treatments (high dose strength and low dose strength), and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability. In each cohort approximately 40 healthy subjects will be randomized to receive treatment with IP to complete at least 32 evaluable subjects.
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| HR20031 FDC | Drug | Subjects will receive treatment HR20031 FDC 10/100/1000 mg in the fed state followed by 7 days washout ,then receive treatment HR20031 FDC 10/100/1000 mg in the fast state. |
|
| HR20031 FDC | Drug | Subjects will receive treatment S HR20031 FDC 5/50/750 mg*2 in the fast state followed by 7 days washout ,then receive treatment HR20031 FDC 5/50/750 mg*2 in the fed state. |
|
| HR20031 FDC | Drug | Subjects will receive treatment HR20031 FDC 5/50/750 mg*2 in the fed state followed by 7 days washout ,then receive treatment HR20031 FDC 5/50/750 mg*2 in the fast state. |
|
| Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SP2086A in the fast and fed state: AUC0-inf (if applicable) | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SHR3824 in the fast and fed state: Tmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SP2086 in the fast and fed state: Tmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SP2086A in the fast and fed state: Tmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of Metformin in the fast and fed state: Tmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SHR3824 in the fast and fed state: Vz/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SP2086 in the fast and fed state: Vz/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SP2086A in the fast and fed state: Vz/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of Metformin in the fast and fed state: Vz/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SHR3824 in the fast and fed state: CL/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SP2086 in the fast and fed state: CL/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SP2086A in the fast and fed state: CL/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of Metformin in the fast and fed state: CL/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SHR3824 in the fast and fed state: t1/2 | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SP2086 in the fast and fed state: t1/2 | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SP2086A in the fast and fed state: t1/2 | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of Metformin in the fast and fed state: t1/2 | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 |
| The incidence and severity of adverse events/serious adverse events | From signed the informed consent form to Day 15 safety visit |
| D004700 | Endocrine System Diseases |