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To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function
This is an 8-day, repeated dose, open label study to investigate the pharmacokinetics and safety of naproxcinod in order to guide initial dosing and achieve the optimal dose of naproxcinod in Renal impaired patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| naproxcinod | Experimental | naproxcinod 750mg(375mg caps x2), administered twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naproxcinod | Drug | 750mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects. | 8 days | |
| To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando | Florida | United States | ||||
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C111751 | naproxen-n-butyl nitrate |
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| 8 days |
| Minneapolis |
| Minnesota |
| United States |
| Saint Paul | Minnesota | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |