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The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | Different fasting time and dosing conditions. |
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| Treatment group B | Experimental | Different fasting time and dosing conditions. |
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| Treatment group C | Experimental | Different fasting time and dosing conditions. |
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| Treatment group D | Experimental | Different fasting time and dosing conditions. |
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| Treatment group E | Experimental | Different fasting time and dosing conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 tablets | Drug | HRS9531 tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau | Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing | 0-24 hours after the 10th dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to maximum plasma concentration | First dose at day 1 and post-dose at day 10. |
| Cmax | The maximum plasma concentration | First dose at day 1 and post-dose at day 10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qianqian Yang | Contact | +86-021-61053363 | qianqian.yang.qy53@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The affiliated hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
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Comparisons between arms with different dosing conditions, timing and food for oral HRS9531 tablets
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| t1/2 | Terminal half-life | First dose at day 1 and post-dose at day 10. |
| Incidence and severity of adverse events | Screening period up to Day 45. |
| Anti-HRS9531 antibody | Before First dose at day 1 to Day 45. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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