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The study is being conducted to evaluate the bioequivalence between a single-dose pen and a multi-dose pen of HRS9531 injection solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group R | Experimental | Multi-dose pen of HRS9531 injection solution. |
|
| Treatment group T | Experimental | Single-dose pen of HRS9531 injection solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 injection | Drug | Multi-dose pen of HRS9531 injection solution. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) | Post-dose at day 1 to day 43. | |
| Area under the concentration curve from time 0 to the last quantifiable concentration (AUClast) | Post-dose at day 1 to day 43. | |
| Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf) | Post-dose at day 1 to day 43. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum plasma concentration (Tmax) | Post-dose at day 1 to day 43. | |
| Terminal half-life (t1/2) | Post-dose at day 1 to day 43. | |
| Apparent clearance (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital Affiliated To Shandong First Medical University | Jinan | Shandong | 250013 | 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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| HRS9531 injection |
| Drug |
Single-dose pen of HRS9531 injection solution. |
|
| Post-dose at day 1 to day 43. |
| Apparent volume of distribution (Vz/F) | Post-dose at day 1 to day 43. |
| Incidence and severity of adverse events (AEs) | Screening period up to day 43. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |