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According to the objective, the trial is constituted by two study groups: one is food effect assessment group, and another is multiple dose pharmacokinetic assessment group.
The primary objective is to (1) assess the effect of a meal (light-fat) on the single-dose PK of SHR3824 and metformin administered in the HR20033 FDC tablet in healthy Chinese subjects; (2) to characterize the single-dose and steady-state PK of SHR3824 and metformin following administration of the HR20033 FDC tablet to healthy subjects in the fed state.
The secondary objective is to assess in healthy Chinese subjects, the safety and tolerability of the SHR3824 and Metformin after single doses (administered in the fed and fasted states) and multiple doses (administered in the fed state) of the HR20033 FDC tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| food effect cohort A | Experimental |
| |
| food effect cohort B | Experimental |
| |
| multiple dose pharmacokinetics | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDC tablet | Drug | single HR20033 FDC tablet fed, take orally on an empty stomach and then after meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Cmax | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-t | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: AUC0-inf | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Cmax | Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times | |
| Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: AUC0-inf | Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times | |
| Pharmacokinetics parameters of SHR3824 and Metformin after multiple dose: Cmax,ss | Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times | |
| Pharmacokinetics parameters of SHR3824 and Metformin after multiple dose: AUCss | Based on pre-dose, 0.5-72 hours post-dose on day 1 and Day 11, pre-dose on Day 8, Day 9, Day 10 sampling times |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Tmax | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 | |
| Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: Vz/F |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230031 | 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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According to the objective, the trial is constituted by two study groups: one is food effect assessment group, and another is multiple dose pharmacokinetic assessment group. There will be 18 (food effect cohort) and 10 (multiple dose pharmacokinetics) volunteers to receive the treatment, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability.
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| FDC tablet | Drug | single HR20033 FDC tablet fasted, take orally after meals and then on an empty stomach |
|
| FDC tablet | Drug | single and multiple doses of HR20033 FDC tablet |
|
| Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: CL/F | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SHR3824 and Metformin in the fasted and fed state: t1/2 | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Tmax | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Ctrough | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 |
| Pharmacokinetics parameters of SHR3824 and Metformin after single and multiple dose: Racc etc | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 |
| The incidence and severity of adverse events/serious adverse events | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 |
| D004700 | Endocrine System Diseases |