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| Name | Class |
|---|---|
| Pharmavite LLC | INDUSTRY |
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The objective of this study is to assess the relative bioavailability of select nutrients from two formulations of a multivitamin/mineral supplement in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation #1 of a multivitamin/mineral supplement | Experimental | Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement |
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| Formulation #2 of a multivitamin/mineral supplement | Active Comparator | Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formulation #1 | Dietary Supplement | Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Baseline-adjusted geometric mean ratio (GMR) for area under the curve (AUC) from 0 to 2 h for plasma folate | Changes in GMR for baseline-adjusted AUC for plasma folate | Baseline to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Unadjusted and baseline-adjusted AUC from 0 to 2 h for select nutrients in plasma | Changes in unadjusted and baseline-adjusted AUC for select nutrients in plasma | Baseline to 2 hours |
| Unadjusted and baseline-adjusted GMRs for AUC from 0 to 2 h for select nutrients in plasma |
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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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| ID | Term |
|---|---|
| C515423 | Akacid-medical-formulation |
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| Formulation #2 | Dietary Supplement | Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement |
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Changes in unadjusted and baseline-adjusted GMRs for AUC for select nutrients in plasma |
| Baseline to 2 hours |
| Unadjusted and baseline-adjusted AUC from 0 to 8 h for select nutrients in plasma | Changes in unadjusted and baseline-adjusted AUC for select nutrients in plasma | Baseline to 8 hours |
| Unadjusted and baseline-adjusted GMRs for AUC from 0 to 8 h for select nutrients in plasma | Changes in unadjusted and baseline-adjusted GMRs for AUC for select nutrients in plasma | Baseline to 8 hours |
| Maximum concentrations of select nutrients in plasma | Differences between study products in unadjusted and baseline-adjusted maximum concentrations of select nutrients in plasma | Baseline to 8 hours |
| Time (in hours) to reach the maximum concentration of select nutrients in plasma | Differences between study products in the time to reach the maximum concentration of select nutrients in plasma | Baseline to 8 hours |
| Concentration of a select nutrient in urine | Differences between study products in the concentration of a select nutrient in urine | Baseline to 24 hours |