Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function | Experimental | GFR between 90-130 ml/min |
|
| Mildly decreased renal function | Experimental | GFR between 60-90 ml/min |
|
| moderately decreased renal function | Experimental | GFR between 30-60 ml/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR4 | Drug | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | Day1-Day29 | |
| AUC0-last | Day1-Day29 | |
| Cmax | Day1-Day29 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAE | Day1-Day29 | |
| AUC0-168h | Day1-Day29 | |
| Tmax |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Suzhou | Jiangsu | China |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day1-Day29 |
| T1/2 | Day1-Day29 |