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the purpose of thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR3824 1Omg,Simavastatin 40mg | Experimental | two 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3824, Simvastatin | Drug | two 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8. |
| 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 coadministration with Simvastatin . | At protocol-specified times up to Day 7 and Day 8 |
| 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 coadministration with Simvastatin . | At protocol-specified times up to Day 7 and Day 8 |
| The area under the plasma concentration-time curve (AUC) of Simvastatin and simavastatin acid . | AUC(a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with SHR3824 . | At protocol-specified times up to Day 1 and Day 8 |
| The maximum plasma concentration (Cmax) of simvastatin and simavastatin acid. | Cmax (a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with Simvastatin . | At protocol-specified times up to Day 1 and Day 8 |
| The number of volunteers with adverse events as a measure of safety and tolerability. | up to day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Liu, PhD | Contact | +86-15705155025 | liuhaiyan@shhrp.com | |
| Jian Chen, Master | Contact | +86-13588084969 | zrygcp@126.com |
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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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| ID | Term |
|---|---|
| C000611095 | henagliflozin |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| D004700 | Endocrine System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |