Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01448031 | A Healthy Female and Male Volunteers Aspirin Study | PHASE1 | COMPLETED | 54 | — | — | Nov 1, 2011 | Apr 1, 2012 | May 10, 2012 | 1 | United Kingdom |
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...