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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20212745 | Other Identifier | NMPA |
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The trial was designed in a single dose, open, non-randomized, multi-dose parallel control group. The study of patients were mild and moderate renal insufficiency, and matched healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy subject | Active Comparator | Matched healthy subjects |
|
| Mild renal insufficiency | Experimental | Mild renal insufficiency was GFR by 60 to 89 mL/min. |
|
| Moderate renal insufficiency | Experimental | Moderate renal insufficiency was GFR by 30 to 59 mL/min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAL067 | Drug | Fasting oral test drug 12mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic characteristics | Peak blood concentration (Cmax) | 8 day |
| Pharmacokinetic characteristics | Area under the curve from 0 to the last time point t (AUC0-last) | 8 day |
| Pharmacokinetic characteristics | Area under the curve from 0 to infinity (AUC0-inf) | 8 day |
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Inclusion Criteria:
Exclusion Criteria:
People who are known to be allergic to DPP-4 inhibitors or drug excipients in this study;
Previous medication history:
Vaccination within 4 weeks prior to screening;
Pregnant or lactating women; The subject and his or her spouse or partner have plans to become pregnant, or plan to donate sperm or eggs, or do not agree to an acceptable and effective method of contraception within 3 months of dosing;
Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, HIV antigen antibody composite test any item is positive。
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | China | 61000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41661440 | Derived | Chen Y, Hu C, Cao X, Men Y, Wang Y, Zhang R, Guan H, Shi L, Liu F, Miao J. Pharmacokinetics, Pharmacodynamics and Safety of Fultagliptin Benzoate Tablets, a DPP-4 Inhibitor, in Patients With Varying Degrees of Renal Insufficiency and Matched Healthy Volunteers: A Phase I Clinical Trial. Clin Pharmacokinet. 2026 Apr;65(4):545-556. doi: 10.1007/s40262-026-01622-8. Epub 2026 Feb 9. |
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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 |