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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be randomized to yield approximately 80 completers. The study is an open label, randomized, 2-way crossover with single dosing followed by a 7-day washout period between treatment arms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | marketed celecoxib |
|
| 2 | Experimental | overencapsulated celecoxib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib | Drug | dose form |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | pre-dose, baseline and multiple times post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sostek, MD | AstraZeneca | Study Director |
| Christopher Billings, DO | Bio-Kinetic Clinical Applications, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research | Springfield | Missouri | United States |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |