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This study aims to compare the relative bioavailability, safety and tolerability of the first-generation and second-generation formulations of HRS9531 tablets, as well as to explore the safety, tolerability and pharmacokinetic characteristics of the second-generation formulation in terms of single-dose escalation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple ascending dose group | Experimental |
| |
| Single ascending dose group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9531 Tablet | Drug | HRS-9531 tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from Time Zero to Time of last quantifiable concentration (AUCtau) | From Day 14 to Day 15. | |
| Adverse event (AE) | Screening period up to Day 35. | |
| Serious adverse event (SAE) | Screening period up to Day 35. |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) | On the 35th day after continuous administration. | |
| Time to maximum plasma concentration (Tmax) | On the 35th day after continuous administration. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Wang | Contact | +86-0518-82342973 | jingjing.wang@hengrui.com | |
| Tong Zhang | Contact | +86-0518-82342973 | tong.zhang.tz58@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230601 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Area under the concentration-time curve (AUC) |
| On the 35th day after continuous administration. |
| Time to maximum plasma concentration (Tmax) | Post-dose from Day 1 to Day 183. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |