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This is a phase â… study to evaluate the relative bioavailability of HRS-9813 capsule and tablet in healthy subjects and the effect of food on the pharmacokinetics of HRS-9813 capsule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-9813 Capsule Group | Experimental |
| |
| HRS-9813 Tablet Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9813 Capsule | Drug | HRS-9813 capsule. |
| |
| HRS-9813 Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration of HRS-9813 capsule (Cmax) | Day 1-Day 23. | |
| Maximum observed concentration of HRS-9813 tablet (Cmax) | Day 1-Day 23. | |
| Area under the concentration-time curve from time 0 to infinity of HRS-9813 tablet (AUC0-inf) | Day 1-Day 23. | |
| Area under the concentration-time curve from time 0 to infinity of HRS-9813 capsule (AUC0-inf) | Day 1-Day 23. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Day 1-Day 23. | |
| Time to Cmax of HRS-9813 capsule (Tmax). | Day 1-Day 23. | |
| Time to Cmax of HRS-9813 tablet (Tmax). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200120 | China |
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| Drug |
HRS-9813 tablet. |
|
| Day 1-Day 23. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |