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This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in patients with impaired hepatic function as compared to healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with im paired hepatic function | Experimental | One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection. |
|
| Healthy Volunteers | Experimental | One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imrecoxib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve from 0 to infinity (AUC0-∞) after a single | First 5 days | |
| Maximum observed plasma drug concentration (Cmax) after a single oral dose of | First 5 days | |
| Time to maximum observed plasma drug concentration (Tmax) after a single oral dose of Imrecoxib. | First 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent terminal half-life (t½) after a single oral dose of Imrecoxib. | First 5 days | |
| Apparent clearance (CL/F) after a single oral dose of Imrecoxib. | First 5 days |
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Inclusion Criteria:
All subjects:
Hepatic impaired subjects:
Exclusion Criteria:
All subjects:
Subjects diagnosed with tumor.
Hepatic impaired subjects:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The frist affiliated hospital of Fourth Military Medical University | Recruiting | Xi’an | Shanxi | 710032 | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C488833 | Imrecoxib |
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| D012216 |
| Rheumatic Diseases |