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Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy volunteers | Experimental | Drug: SHR3824 20mg/day, oral tablet, single dose |
|
| Mild Hepatic Impairment | Experimental | Drug: SHR3824 20mg/day, oral tablet, single dose |
|
| Moderate Hepatic Impairment | Experimental | Drug: SHR3824 20mg/day, oral tablet, single dose |
|
| Severe Hepatic Impairment | Experimental | Drug: SHR3824 20mg/day, oral tablet, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR3824 | Drug | Drug: SHR3824 20mg/day, oral tablet, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma concentration-time curve (AUC) of SHR3824 | AUC (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients | 72 hours after dosing |
| The maximum plasma concentration (Cmax) of SHR3824 | Cmax (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients. | 72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| The number of volunteers with adverse events as a measure of safety and tolerability | The number of volunteers with adverse events as a measure of safety and tolerability | 72 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XinMin Zhou | Contact | 029-84775507 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| XiJing Hospital | Recruiting | XiAn | Shanxi | 710032 | China |
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| ID | Term |
|---|---|
| C000611095 | henagliflozin |
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