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The purpose of this study is to demonstrate the relative bioavailability of Naproxen delayed-release tablets (375 mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.) |
|
| 2 | Active Comparator | Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.) | Drug |
| ||
| Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on AUC and Cmax | 55 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Goldwater, M.D. | PharmaKinetics Laboratories Inc. | Principal Investigator |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |