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This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: Retagliptin Phosphate Tablet | Experimental |
| |
| Treatment group B: Retagliptin Phosphate Tablet | Experimental |
| |
| Treatment group C: Retagliptin Phosphate Tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retagliptin Phosphate Tablet | Drug | Retagliptin Phosphate Tablet;100mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters:Cmax; | 0hour to 72hours after the last dosing | |
| PK parameters:AUC0-t; | 0hour to 72hours after the last dosing | |
| PK parameters:AUC0-∞; | 0hour to 72hours after the last dosing |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters:Tmax; | 0hour to 72hours after the last dosing | |
| PK parameters:t1/2; | 0hour to 72hours after the last dosing | |
| PK parameters:CL/F; |
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Inclusion Criteria:
Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions; And be able to complete the research according to the requirements of the test plan;
The subjects (including their partners) are willing to voluntarily take effective contraceptive measures from screening until 2 weeks after the last study drug administration, as specified in Appendix 1;
Age 18-70 years old (including the critical value), both male and female;
The weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg. Body mass index (BMI) : 18-32 kg/m2 (including the cut-off value);
(Only for subjects with normal liver function) The demographic mean of subjects in the normal liver function group (Group C) at screening must meet the following matching criteria:
(Only for subjects with normal liver function) Normal or abnormal clinical laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) have no clinical significance.
(Only for subjects with normal liver function) No prior serious primary diseases of major organs, including but not limited to gastrointestinal, respiratory, kidney, liver, nervous, blood, endocrine, tumor, immune, psychiatric or cardiovascular and cerebrovascular diseases
(Only for subjects with liver function impairment) Those who had not taken medication within 4 weeks prior to screening, or who had at least 4 weeks of stable medication for liver impairment and/or other comorbidification requiring long-term treatment
(Only for subjects with liver function impairment) Patients with liver insufficiency due to previous primary liver disease with Child-Pugh grade A or B.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Feng | Contact | +86-0518-82342973 | sheng.feng@hengrui.com | |
| Xihan Wang | Contact | +86-0518-82342973 | xihan.wang@hengrui.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 0hour to 72hours after the last dosing |
| PK parameters:V/F; | 0hour to 72hours after the last dosing |
| Incidence and severity of adverse events (AEs) | from screening to 168 hours after the last dosing |