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The purpose of this study is to assess the bioequivalence between HR20031 FDC tablet and co-administration of SHR3824 tablets, SP2086 tablets and metformin XR tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A:SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2 | Experimental |
| |
| ARM B:HR20031 FDC 10/100/1000 mg | Experimental |
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| ARM C:SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2 | Experimental |
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| ARM D:SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3 | Experimental |
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| ARM E:HR20031 FDC 5/50/750 mg*2 | Experimental |
| |
| ARM F:SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARM A | Drug | Subjects will receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2 followed by 7 days washout ,then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2 followed by 7 days washout and then receive treatment HR20031 FDC 10/100/1000 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of SHR3824 in the fed state: Cmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 | |
| Pharmacokinetics parameters of SP2086 in the fed state: Cmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 | |
| Pharmacokinetics parameters of Metformin in the fed state: Cmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 | |
| Pharmacokinetics parameters of SHR3824 in the fed state: AUC0-t | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 | |
| Pharmacokinetics parameters of SP2086 in the fed state: AUC0-t | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 | |
| Pharmacokinetics parameters of Metformin in the fed state: AUC0-t | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 | |
| Pharmacokinetics parameters of SHR3824 in the fed state: AUC0-inf (if applicable) | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 | |
| Pharmacokinetics parameters of SP2086 in the fed state: AUC0-inf (if applicable) | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 | |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of SP2086A in the fed state: Cmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 | |
| Pharmacokinetics parameters of SP2086A in the fed state: AUC0-t | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital | Jinan | Shandong | 250013 | 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 42 healthy subjects will be randomized to receive treatment with IP to complete at least 36 evaluable subjects.
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| ARM B | Drug | Subjects will receive treatment HR20031 FDC 10/100/1000 mg followed by 7 days washout ,then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2 followed by 7 days washout and then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2. |
|
| ARM C | Drug | Subjects will receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2 followed by 7 days washout ,then receive treatment HR20031 FDC 10/100/1000 mg followed by 7 days washout and then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2. |
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| ARM D | Drug | Subjects will receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3 followed by 7 days washout ,then receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3 followed by 7 days washout and then receive treatment HR20031 FDC 5/50/750 mg*2. |
|
| ARM E | Drug | Subjects will receive treatment HR20031 FDC 5/50/750 mg*2 followed by 7 days washout ,then receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3 followed by 7 days washout and then receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3. |
|
| ARM F | Drug | Subjects will receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3 followed by 7 days washout ,then receive treatment HR20031 FDC 5/50/750 mg*2 followed by 7 days washout and then receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3. |
|
| Pharmacokinetics parameters of Metformin in the fed state: AUC0-inf (if applicable) |
| Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| Pharmacokinetics parameters of SP2086A in the fed state: AUC0-inf (if applicable) | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| Pharmacokinetics parameters of SHR3824 in the fed state: Tmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| Pharmacokinetics parameters of SP2086 and SP2086A in the fed state: Tmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| Pharmacokinetics parameters of Metformin in the fed state: Tmax | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| Pharmacokinetics parameters of SHR3824 in the fed state: CL/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| Pharmacokinetics parameters of SP2086 and SP2086A in the fed state: CL/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| Pharmacokinetics parameters of Metformin in the fed state: CL/F | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| Pharmacokinetics parameters of SHR3824 in the fed state: t1/2 | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| Pharmacokinetics parameters of SP2086 and SP2086A in the fed state: t1/2 | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| Pharmacokinetics parameters of Metformin in the fed state: t1/2 | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| The incidence and severity of adverse events/serious adverse events | Based on pre-dose, 0.25-72 hours post-dose sampling times on Day 1 and Day 8 and Day 15 |
| D004700 | Endocrine System Diseases |