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This study aims to evaluate the interaction of oral HRS-9813 capsules with pirfenidone and nintedanib on the pharmacokinetics of healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-9813 Capsule or Nintedanib Soft Capsules or Pirfenidone Tablets Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9813 Capsule | Drug | HRS-9813 capsule, specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) | From Day 1 to Day 24. | |
| Area under the concentration curve from time 0 to extrapolated infinite time (AUC0-inf) | From Day 1 to Day 24. | |
| Area under the concentration curve from time 0 to time of last quantifiable concentration (AUC0-tau) | From Day 1 to Day 24. | |
| Area under the concentration curve from time 0 to time t (AUC0-t) | From Day 1 to Day 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Accumulative excretion rate (Ae) | Day 1, Day 19 and Day 20. | |
| Fractional excretion (Fe) | Day 1, Day 19 and Day 20. | |
| Renal clearance (CLr) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruifang Guan | Contact | +86-0518-82342973 | ruifang.guan.rg1@hengrui.com | |
| Ye Xu | Contact | +86-0518-82342973 | ye.xu.yx1@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital, Fourth Military Medical University | Recruiting | Xi’an | Shanxi | 710026 | 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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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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| Nintedanib Soft Capsules | Drug | Nintedanib soft capsules, specified dose on specified days. |
|
| Pirfenidone Tablets | Drug | Pirfenidone tablets, specified dose on specified days. |
|
| Day 1, Day 19 and Day 20. |
| Adverse events (AEs) | From Day 1 to Day 30. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |