Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Acetylsalicyclic acid (Fast release Aspirin, BAY1019036), Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036)
Acetylsalicyclic acid · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Arm 3 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Acetylsalicyclic acid (Fast release Aspirin, BAY1019036) | DRUG | Single oral dose of fast release aspirin tablet 1000 mg (2 x 500 mg) and 2 placebo-matching acetaminophen caplets with a full glass of water (240 milliliter \[mL\]) between 1-4 hours post dental surgery. |
| Acetaminophen (Tylenol extra strength) | DRUG | Single oral dose of acetaminophen (Tylenol extra strength) caplet 1000 mg (2 x 500 mg) and 2 placebo matching aspirin tablets with a full glass of water (240 mL) between 1-4 hours post dental surgery. |
| Placebo | DRUG | Single oral dose of placebo (2 placebo aspirin tablets and 2 placebo acetaminophen caplets) with a full glass of water (240 mL) between 1-4 hours post dental surgery. |
| Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036) | DRUG | Single dose of fast acting aspirin 2 x 325 mg = 650 mg total |
| Acetylsalicyclic acid (Aspirin, BAYE4465) | DRUG | Single dose of regular aspirin 2 x 325 mg = 650 mg total |
Inclusion Criteria: * Healthy, ambulatory, male and female volunteers between 16 to 45 years of age * Scheduled to undergo surgical removal of either two partial bony impactions or one full bony alone or in combination with a partial bony impaction, soft tissue impaction or erupted third molar. Max...