Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the bioequivalence of new formula of aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Active Comparator |
| |
| Arm 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic acid (Aspirin, BAY1019036) | Drug | One oral dose of new formula Aspirin Prototype 1 under fasting conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence of new formula aspirin relative to the established commercial aspirin plain tablet and aspirin dry granules when taken orally by healthy adult subjects | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety and tolerability of the new aspirin formula | 24 hours | |
| To assess additional pharmacokinetic parameters | 24 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack | New Jersey | 07601 | United States |
Not provided
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Acetylsalicylic acid (Aspirin, BAY1019036) | Drug | One oral dose of new formula Aspirin Prototype 2 under fasting conditions |
|
| Acetylsalicylic acid (Aspirin, BAYE4465) | Drug | One oral dose of Aspirin Plain Tablet under fasting conditions |
|
| Acetylsalicylic acid (Aspirin, BAYE4465) | Drug | One oral dose of Aspirin Dry Granules under fasting conditions |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |