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| Name | Class |
|---|---|
| Pharmavite LLC | INDUSTRY |
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This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation compared with a standard omega-3-acid ethyl ester product in healthy men and women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA + DHA in SMEDS Formulation | Experimental | Subject will receive a single 500 mg oral dose of EPA + DHA in a SMEDS formulation |
|
| EPA + DHA (Lovaza) | Active Comparator | Subject will receive a single 840 mg oral dose of EPA + DHA as Lovaza |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA + DHA in SMEDS Formulation | Dietary Supplement | A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-adjusted, dose-normalized geometric mean ratio for SMEDS/Lovaza for EPA + DHA area under the curve (AUC) 0-24 hours | 0-24 h on Days 0-1 and on Days 14-15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin C Maki, PhD | MB Clinical Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MB Clinical Research, LLC | Boca Raton | Florida | 33487 | United States | ||
| Great Lakes Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30454850 | Derived | Maki KC, Palacios OM, Buggia MA, Trivedi R, Dicklin MR, Maki CE. Effects of a Self-micro-emulsifying Delivery System Formulation Versus a Standard omega-3 Acid Ethyl Ester Product on the Bioavailability of Eicosapentaenoic Acid and Docosahexaenoic Acid: A Study in Healthy Men and Women in a Fasted State. Clin Ther. 2018 Dec;40(12):2065-2076. doi: 10.1016/j.clinthera.2018.10.014. Epub 2018 Nov 16. |
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| ID | Term |
|---|---|
| C405603 | Omacor |
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| Lovaza (active comparator; already FDA approved) | Other | A single dose of 840 mg EPA + DHA administered as Lovaza. This intervention was used as an active comparator in this study. Lovaza was already FDA-approved when the study was conducted. |
|
| Chicago |
| Illinois |
| 60640 |
| United States |