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The purpose of the study is to investigate the potential interaction between multiple oral doses of SHR3824 and a single oral dose of metformin in healthy adult volunteers.
This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SHR3824 and metformin in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM. SHR3824 will be administered orally (by mouth) as 25 mg on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 500mg tablets on Days 1 and 8. Both SHR3824 and metformin tablets will be taken with 8 ounces (240 mL) of water.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR3824 25mg/metformin 1000mg | Experimental | Two 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3824 metformin | Drug | Two 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8. Drug: SHR3824 + Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) of SHR3824. | Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin. | At protocol-specified times up to Day 9. |
| The area under the plasma concentration-time curve (AUC) of SHR3824. | AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of a single dose of metformin. | At protocol-specified times up to Day 9. |
| The maximum plasma concentration (Cmax) of metformin. | Cmax (a measure of the body's exposure to metformin) will be compared. before and after administration of multiple doses of SHR3824 | At protocol-specified times up to Day 9. |
| The area under the plasma concentration-time curve (AUC) of metformin | AUC (a measure of the body's exposure to metformin) will be compared before and after administration of multiple doses of SHR3824. | At protocol-specified times up to Day 9. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability. | Up tp day 9. |
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Inclusion Criteria:
Exclusion Criteria:
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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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| D004700 | Endocrine System Diseases |