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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
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Turmeric is recognized as a bioactive compound with potential benefits for human health. This study compares the pharmacokinetic profile of the Turmeric test product to a comparator.
This randomized, double-blinded, comparator-controlled, crossover study will compare the pharmacokinetic profile of the Turmeric test product to a comparator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Turmeric test product | Experimental | Turmeric |
|
| Turmeric comparator | Active Comparator | Turmeric |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turmeric test product | Dietary Supplement | 2 capsules of 490 mg Turmeric are taken with water once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics- Area under the plasma concentration-time curve for 8 hours (AUC0-8h) | Test products area under the plasma concentration-time curve for 8 hours (AUC0-8h) | 8 hours |
| Pharmacokinetics- Peak plasma concentration (Cmax) | Test products Peak plasma concentration (Cmax) | 8 hours |
| Pharmacokinetics- Time to reach Cmax (Tmax) | Test products Time to reach Cmax (Tmax) | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics- Total area under the curve (observed from 0-8 hours, and extrapolated from 8 hours to infinity) [AUC(0-∞)] | Test products Total area under the curve (observed from 0-8 hours, and extrapolated from 8 hours to infinity) [AUC(0-∞)] | 8 hours |
| Pharmacokinetics- Half-life (T1/2) |
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Inclusion Criteria:
Healthy adult participants who are 18 to 49 years of age (inclusive).
In good general health (no active or uncontrolled diseases or conditions) and is able to consume the study product.
Have a body mass index between 18.5 to 24.9 kg/m2 (inclusive).
Have normal or acceptable to the investigator heart rate at screening.
Individuals with childbearing potential should have a negative pregnancy test at baseline and must agree to practice an acceptable form of non-hormonal birth control throughout the study, including but not limited to:
Must have suitable veins for repeated venipuncture.
Able to swallow pills or capsules whole and without chewing.
Willing and able to comply with the protocol, including:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Bier, MD | Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrasource Clinical Trial Site | Guelph | Ontario | N1G 0B4 | Canada |
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Randomization at 1:1 ratio for test product or comparator
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| Turmeric comparator | Dietary Supplement | 2 capsules of 200 mg Turmeric are taken with water once |
|
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Test products Half-life (T1/2) |
| 8 hours |
| Pharmacokinetics- Terminal elimination rate constant (Kel) | Test products Terminal elimination rate constant (Kel) | 8 hours |
| Safety- participants experiencing adverse events | The number of participants experiencing Treatment Emergent Adverse Events (TEAEs) | 8 days |
| Safety- adverse events | The total number Treatment Emergent Adverse Events (TEAEs) | 8 days |