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This study was designed as a a single-center, randomized, open, interleaved (3-cycle, 3-sequence) trial. It is planned to enroll 18 healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
| |
| Treatment group C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535(D) Tablets | Drug | One HRS-7535(D) Tablet is administered to healthy subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters:Cmax | 0 hour to 72 hours after the last dosing | |
| PK parameters:AUC0-t | 0 hour to 72 hours after the last dosing | |
| PK parameters:AUC0-∞ | 0 hour to 72 hours after the last dosing | |
| Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal | 0 hour to 72 hours after the last dosing | |
| Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status | 0 hour to 72 hours after the last dosing |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters:Tmax | 0 hour to 72 hours after the last dosing | |
| PK parameters: t1/2 | 0 hour to 72 hours after the last dosing | |
| PK parameters: CL/F |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical Uniersity | Hefei | Anhui | 230601 | China |
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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 |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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This study was an open, fixed-sequence clinical trial in healthy adult subjects
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| HRS-7535(C) Tablets | Drug | Two HRS-7535(C) Tablets is administered to healthy subjects. |
|
| 0 hour to 72 hours after the last dosing |
| PK parameters: V/F | 0 hour to 72 hours after the last dosing |
| Incidence and severity of adverse events (AEs) | from screening to 72 hours after the last dosing |
| D004700 | Endocrine System Diseases |