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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02310022 | A PK and PD Study of Two Formulations of Omega-3 One Gram Capsules | PHASE1 | COMPLETED | 48 | — | — | Nov 1, 2014 | Aug 1, 2016 | Oct 12, 2020 | 1 | Canada |
Area under the plasma concentration curve versus time curve (AUC0-tau) versus time curve (AUC0-tau) for both treatments measured over the 24 hour period on day 1 and day 14 \[ Time Frame: 14 days \]
| Arm | Type | Description |
|---|---|---|
| Drug Omega 3 | EXPERIMENTAL | 4g (4 capsules) once a day, administered with food Other name MAT9001 |
| Drug Omega 3 Comparator | ACTIVE_COMPARATOR | 4g (4 capsules) once a day, administered with food Other name Omega 3 Active Comparator |
| Name | Type | Description |
|---|---|---|
| Drug Omega 3 | DRUG | 4 g (4 capsules) once a day, administered with food |
| Drug Omega-3 Comparator | DRUG | 4 g (4 capsules) once a day, administered with food |
Inclusion Criteria: Subjects must fulfil all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified: 1. Adult male or female subject, 18-70 years of age, inclusive. 2. Light- or non-smoking, male and female subjects, 18 to 70 years of age. Not...