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We will evaluate the bioavailability of naproxen 375 mg in two formulations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | PN400 |
|
| 2 | Active Comparator | naproxen 375 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PN400 | Drug | naproxen 375 mg / esomeprazole 20 mg |
| |
| Naproxen |
| Measure | Description | Time Frame |
|---|---|---|
| To assess and compare the pharmacokinetics bioavailability of a single oral dose of naproxen administered in two formulations | 72-hour PK |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of the two treatments | entire study duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | United States |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal 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 |
naproxen 375 mg |
|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |