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| Name | Class |
|---|---|
| Naturmega | UNKNOWN |
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The objective of this study is to assess the relative bioavailability of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in two supplement products in healthy adult men and women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA + DHA Ruby-O | Experimental | Subject will receive a single 1000 mg oral dose of EPA + DHA Ruby-O capsule |
|
| EPA + DHA Krill Oil | Active Comparator | Subject will receive a single 1000 mg oral dose of EPA + DHA krill oil capsule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA + DHA Ruby-O | Dietary Supplement | Subject will receive a single 1000 mg oral dose of EPA + DHA Ruby-O capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline-adjusted geometric mean ratio for EPA + DHA AUC | Changes in baseline-adjusted geometric mean ratio for EPA + DHA AUC | Baseline to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Unadjusted maximum concentrations for EPA, DHA, and EPA + DHA | Changes in unadjusted maximum concentrations for EPA, DHA, and EPA + DHA | Baseline to 24 hours |
| Unadjusted AUC for EPA, DHA, and EPA + DHA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin C Maki, PhD | MB Clinical Research & Consulting | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Awareness | Port Saint Lucie | Florida | 34952 | United States |
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| EPA + DHA Krill Oil | Dietary Supplement | Subject will receive a single 1000 mg oral dose of EPA + DHA krill oil capsule |
|
Changes in unadjusted AUC for EPA, DHA, and EPA + DHA
| Baseline to 24 hours |
| Baseline-adjusted maximum concentration for EPA, DHA, and EPA + DHA | Changes in baseline-adjusted maximum concentration for EPA, DHA, and EPA + DHA | Baseline to 24 hours |
| Baseline-adjusted AUC for EPA and DHA | Changes in baseline-adjusted AUC for EPA and DHA | Baseline to 24 hours |
| Baseline-adjusted, dose-normalized maximum concentration for EPA, DHA, and EPA + DHA | Changes in baseline-adjusted, dose-normalized maximum concentration for EPA, DHA, and EPA + DHA | Baseline to 24 hours |
| Baseline-adjusted, dose-normalized AUC for EPA, DHA, and EPA + DHA | Changes in baseline-adjusted, dose-normalized AUC for EPA, DHA, and EPA + DHA | Baseline to 24 hours |
| Time to maximum concentration for EPA, DHA, and EPA + DHA | Changes in time to maximum concentration for EPA | Baseline to 24 hours |