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To determine the bioequivalence of new formula of aspirin relative to the established commercial effervescent aspirin when taken orally by healthy adult subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Active Comparator |
| |
| Arm 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic Acid (Aspirin BAY1019036) | Drug | One tablet of new formula Aspirin under fasting conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability of new formulation aspirin versus marketed effervescent tablets (500mg aspirin) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event collection | 24 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 |
|---|---|---|---|---|---|---|
| Hackensack | New Jersey | 07601 | United States |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D054477 | Glutaredoxins |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Alka Seltzer Extra Strength | Drug | One effervescent tablet under fasting conditions |
|
| Aspirin Migraine | Drug | One effervescent tablet under fasting conditions |
|
| Aspirin Aspro | Drug | One effervescent tablet under fasting conditions |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D050862 | Oxidoreductases Acting on Sulfur Group Donors |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |