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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...
Acetylsalicyclic acid is being studied in Phase 3 trials for investigational use and in healthy subjects. Bayer AG is developing a fast release formulation, coded BAY1019036, to evaluate onset of action and analgesic efficacy. It is a small molecule drug and remains investigational in these studies.
Acetylsalicyclic acid is developed by Bayer AG, which trades under the ticker BAYRY. The company is running Phase 3 trials of a fast release aspirin formulation, also known as BAY1019036, in the United States.
Acetylsalicyclic acid is in Phase 3 clinical development. The program includes completed Phase 3 trials, and no active trials are currently listed. It is an investigational fast release aspirin formulation being studied in healthy subjects and for analgesic efficacy.
Acetylsalicyclic acid has been studied in two completed Phase 3 trials: NCT01420094, which evaluated onset of action in 510 healthy subjects, and NCT01122602, which evaluated analgesic efficacy in 500 participants. Both were randomized, double-blind, placebo-controlled studies conducted in the United States.
Yes, acetylsalicyclic acid is also known as fast release aspirin and fast acting aspirin, with the development code BAY1019036. These names refer to the same Bayer AG investigational formulation studied in Phase 3 trials for onset of action and analgesic efficacy.