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A pharmacokinetic study evaluating naproxen and esomeprazole blood levels in 4 treatments, each containing one or both components.
This study is being conducted to assess the relative bioavailability of naproxen and esomeprazole from a single dose of PN 400 (delayed-release naproxen 500mg / immediate-release esomeprazole 20mg), enteric-coated naproxen 500mg co-administered with enteric-coated esomeprazole 20mg, enteric-coated naproxen 500mg administered alone, and enteric-coated esomeprazole 20mg administered alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | PN 400 |
|
| 2 | Active Comparator | Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule(20mg) |
|
| 3 | Active Comparator | Enteric-coated naproxen tablet (500mg) |
|
| 4 | Active Comparator | EC esomeprazole capsule (20mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PN 400 | Drug | A single tablet containing delayed-release naproxen (500mg) plus immediate-release esomeprazole (20mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the single-dose pharmacokinetics and relative bioavailability of esomeprazole in PN 400 (naproxen 500mg / esomeprazole 20mg), the enteric-coated (EC) naproxen 500mg plus EC esomeprazole 20mg and the EC esomeprazole 20mg alone treatments | 12-72 hour PK assessments |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the single-dose pharmacokinetics and relative bioavailability of naproxen in PN 400 (naproxen 500mg / esomeprazole 20mg, the EC naproxen 500mg plus EC esomeprazole 20mg, and the EC naproxen 500mg alone treatments. | 72-hour PK assessments | |
| To evaluate the safety of each of the single-dose treatments |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Austin | Texas | 78744 | 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 |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| EC naproxen plus EC esomeprazole | Drug | Enteric-coated naproxen tablet (500mg) plus enteric-coated esomeprazole capsule (20mg) |
|
|
| EC naproxen | Drug | Enteric-coated naproxen tablet (500mg) |
|
|
| EC esomeprazole | Drug | Enteric-coated esomeprazole capsule (20mg) |
|
|
| Entire study duration (48 days) |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |