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This study is a single-center, single-dose, randomized, open-label, two-period, crossover phase I clinical trial, comparing the bioavailability and safety of the new and old processes of HRS-2189 tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-2189 of new process | Experimental | HRS-2189 of new process. |
|
| HRS-2189 of old process | Experimental | HRS-2189 of old process. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2189 Tablet | Drug | HRS-2189 tablet, oral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) | Day1 - Day37. | |
| From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration (AUC0-t) | Day1 - Day37. | |
| Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf) | Day1 - Day37. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum plasma concentration (Tmax) | Day1 - Day37. | |
| Terminal half-life (t1/2) | Day1 - Day37. | |
| Apparent clearance (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingyi Qu | Contact | +86-0518-82342973 | xingyi.qu.xq5@hengrui.com | |
| Shaorong Li | Contact | +86-0518-82342973 | shaorong.li@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
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This study uses a single-center, single-dose, randomized, open-label, two sequences, two period and crossover design.
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| Day1 - Day37. |
| Apparent volume of distribution (Vz/F) | Day1 - Day37. |
| Incidence and severity of adverse events (AEs) | Safety measure. | Day1 - Day37. |