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The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets.
The primary objective is to evaluate bioequivalence of SHR3824 and Metformin in healthy Chinese subjects in the fed state.
The secondary objective is to evaluate the safety of HR20033 FDC tablet in healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR20033 FDC 5/500 mg | Experimental |
| |
| SHR3824 5mg + Metformin 500 mg XR | Experimental |
| |
| HR20033 FDC 5/1000 mg | Experimental |
| |
| SHR3824 5 mg + Metformin 1000 mg XR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR | Drug | SHR3824 5 mg + Metformin 500 mg XR In cohort 1 (low dose strength), subjects will receive treatment T1 followed by 7 days washout and then receive treatment R1+R. |
| 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 (if applicable) | Based on pre-dose, 0.5-72 hours post-dose sampling times on Day 1 and Day 8 |
| 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Feng, Ph.D | Contact | 13817253036 | Sheng.feng@hengrui.com | |
| Jing Rao, M.M | Contact | 17612186457 | jing.rao@hengrui.com |
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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 36 evaluable subjects.
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| T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR | Drug | SHR3824 5 mg + Metformin 500 mg XR In cohort 1 (low dose strength), subjects will receive treatment R1+R followed by 7 days washout and then receive treatment T1. |
|
| T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR | Drug | SHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment T2 followed by 7 days washout and then receive treatment R2+R. |
|
| T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR | Drug | SHR3824 5 mg + Metformin 1000 mg XR In cohort 2 (high dose strength), subjects will receive treatment R2+R followed by 7 days washout and then receive treatment T2. |
|
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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