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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01486433 | The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects | PHASE1 | COMPLETED | 52 | — | — | Nov 1, 2011 | Mar 1, 2012 | Apr 30, 2015 | 1 | United States |
Area under the plasma concentration versus time curve (AUC0-tau)for simvastatin and beta- hydroxysimvastatin acid, measured over the 24 hour period after the 14th dose
Maximum measured plasma concentration for simvastatin and beta- hydroxysimvastatin acid,during the 0-24 hour dosing interval for the 14th simvastatin dose (Day 14)measured over the 24 hour period after the 14th dose.
| Arm | Type | Description |
|---|---|---|
| Epanova and Simvastatin | EXPERIMENTAL | - |
| Simvastatin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Simvastatin | DRUG | 40 mg (1 tablet) simvastatin once a day |
| acetylsalicylic acid (ASA) | DRUG | 81 mg aspirin (1 tablet), once a day, co-administered with simvastatin |
| omefas | DRUG | 4 g (4 capsules) Epanova once a day, co-administered with simvastatin and aspirin |
Inclusion Criteria: Subjects must fulfil all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified: 1. Healthy adult male or female volunteers, 18-55 years of age, inclusive. 2. Body mass index (BMI) ≥ 18 and ≤ 29.9 (kg/m2). 3. Medically heal...