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This is an open-label study that will compare the pharmacokinetic and safety effects of naproxcinod in hepatic impaired patients vs. matching healthy subjects.
This is an open-label, non-randomized, parallel-group study that will be conducted at two study sites. Patients with hepatic impairment and matched healthy subjects will receive naproxcinod 750 mg bid for 6 days and qd for the last day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 750 mg naproxcinod |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naproxcinod | Drug | 750 mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics of naproxcinod and its metabolites after repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patient in comparison with matching healthy subjects | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety and tolerability of repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patients in comparison with matching healthy subjects. | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | United States |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C111751 | naproxen-n-butyl nitrate |
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