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The purpose of this study is to provide information on how well an extended release formulation (a medication that is released and absorbed over a longer period of time than a regular release formulation of the medication) of naproxen sodium is absorbed into the bloodstream after eating a high calorie breakfast and also after fasting (not eating for 14 hours).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other |
| |
| Arm 2 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen sodium | Drug | Administered under fasting condition |
| |
| Naproxen sodium |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters | Over 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the tolerability of the investigational product. | Over 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72202 | United States |
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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 |
Administered under fed condition |
|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |