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Acetylsalicylzuur Apotex Cardio · 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...
Acetylsalicylzuur Apotex Cardio is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It has been studied in healthy adult volunteers rather than in patients with a specific disease. Its clinical development is at Phase 1, and the program includes one completed trial.
Acetylsalicylzuur Apotex Cardio has been studied in healthy volunteers, not in a patient population with a defined disease. The single completed trial enrolled healthy female and male participants aged 20 years and older in the United Kingdom, so no therapeutic indication has been established for this asset.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of Acetylsalicylzuur Apotex Cardio. The company sponsored the clinical program for this small molecule asset, which has been evaluated in a Phase 1 study conducted in the United Kingdom.
Acetylsalicylzuur Apotex Cardio is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program has not advanced beyond early clinical testing, and the drug remains investigational.
Acetylsalicylzuur Apotex Cardio has been evaluated in one completed Phase 1 trial, NCT01448031, titled A Healthy Female and Male Volunteers Aspirin Study. It enrolled 54 healthy volunteers in the United Kingdom, was randomized and active controlled, and included both female and male participants aged 20 years and older.