Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ASA/esomeprazole · 1 trial · 1 indication
PK samples collected pre-dose and at 5mins, 10 mins, 20 mins, 30 mins, 40mins, 50 mins, 1hr 15 mins, 1.5hrs, 2 hrs, 2hr 30 mins, 3hrs, 3hr 30 mins, 4 hrs, 5 hrs, 6hrs, 8hrs,10 hrs, 12hrs post-dose.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Capsule ASA 81mg/esomeprazole 20mg |
| 2 | ACTIVE_COMPARATOR | ASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg |
| Name | Type | Description |
|---|---|---|
| Capsule ASA 81mg/esomeprazole 20mg | DRUG | Multiple doses administered on Day 1 to 5 |
| Acetylsalicylzuur Apotex Cardio | DRUG | Multiple doses administered on Day 1 to 5 |
Inclusion Criteria: * Healthy male and female subjects aged 20 to 50 years inclusive. * Have a body body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and weigh 50.0 to 100.0 kg inclusive. * Females must be of non-childbearing potential or be of childbearing potential but have a negative serum h...
ASA is an investigational small molecule being studied for use in peptic ulcer disease, ulcers, and upper GI symptoms, as well as in healthy volunteers. It is currently in Phase 1 clinical development by AstraZeneca PLC.
AstraZeneca PLC (ticker: AZN) is developing ASA. The drug is an investigational small molecule in Phase 1 clinical trials for gastrointestinal conditions.
ASA is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials are Phase 1 studies.
ASA has been studied in three completed Phase 1 trials: NCT00688428, NCT00998075, and NCT01448031. These trials evaluated ASA in healthy volunteers and patients with ulcers or peptic ulcer disease.
ASA is an abbreviation for acetylsalicylic acid, which is aspirin. In clinical trials, ASA is being studied in combination with esomeprazole for gastrointestinal conditions.