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Each year, there are about 150,000 new colorectal cancer (CRC) cases and 50,000 CRC deaths in the United States. A safe and effective preventive agent could reduce the burden of colorectal cancer as well as reduce the costs associated with screening patients who are at high risk of developing CRC. Preclinical studies strongly suggest that curcumin is active against multiple pathways implicated in tumor initiation, progression, and metastasis. However, little is know how curcumin performs in humans. The investigators propose to enroll 12 healthy volunteers who will undergo blood draw and rectal biopsy after 7 days of curcumin administration. The investigators will look at curcumin preparations with low and high oral bioavailability and calculate the blood and rectal tissue concentrations associated with these two formulations to determine which preparation produces the highest tissue concentrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C3 tablet | Active Comparator | 4g C3 tablet |
|
| Meriva | Active Comparator | 2g Meriva powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| curcumin | Drug | standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under plasma concentration curve from 0-48h using 13 time points. | 0-48h |
| Cmax | Maximum curcumin plasma concentration | 0-48h |
| Tmax | Time to maximum curcumin plasma concentration | 0-48h |
| Ke | Terminal elimination rate | 0-48h |
| T1/2 | plasma curcumin concentration half-life | 0-48h |
| Vd | Volume of distribution | 0-48h |
| Test of bioequivalence | geometric mean ratio of plasma AUC0-48h of the two formulations | 0-48h |
| bioequivalence of tissue curcumin concentration | comparison of curcumin concentration in colorectal tissue at single time point between two formulations | 1h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary N Asher, MD, MPH | UNC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Department of Family Medicine | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27503249 | Result | Asher GN, Xie Y, Moaddel R, Sanghvi M, Dossou KS, Kashuba AD, Sandler RS, Hawke RL. Randomized Pharmacokinetic Crossover Study Comparing 2 Curcumin Preparations in Plasma and Rectal Tissue of Healthy Human Volunteers. J Clin Pharmacol. 2017 Feb;57(2):185-193. doi: 10.1002/jcph.806. Epub 2016 Sep 6. |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |