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The study is being conducted to evaluate the safety and pharmacokinetics of HR19042 capsule after single administration in healthy Chinese subjects. To explore the pharmacokinetic characteristics and safety of HR19042 capsule in healthy Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR19042 capsule | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR19042 capsule | Drug | phase 1 :8mg; phase 2:12mg; phase 3:16mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak concentration of drug observed from 0 hour to 24 hours after administration | 0-24 hours |
| AUC0-t; | The area under the drug concentration-time curve at the sample collection time t that can be accurately determined from 0 hour to 24 hours after administration | 0-24 hours |
| AUC0-∞ | The area under the concentration-time curve of drug from 0 hour to infinity after administration | 0 hour to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Adverse event | Screening period to end of follow-up period, approximately 1 month |
| the change of blood cortisol AUC0-24h from baseline after each cycle of administration | 0-24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200231 | China |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Single center, open, three-period, sequential design
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |