Curcumin Pharmacokinetics

Crossover, Multiple Dose Pharmacokinetics of Two Curcumin Formulations in Healthy Volunteers

Sponsors

Lead Sponsor: University of North Carolina, Chapel Hill

Source University of North Carolina, Chapel Hill
Brief Summary

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.

Overall Status Completed
Start Date 2011-03-01
Completion Date 2012-04-01
Primary Completion Date 2011-12-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
AUC 0-48h
Cmax 0-48h
Tmax 0-48h
Ke 0-48h
T1/2 0-48h
Vd 0-48h
Test of bioequivalence 0-48h
bioequivalence of tissue curcumin concentration 1h
Enrollment 12
Condition
Intervention

Intervention Type: Drug

Intervention Name: curcumin

Description: standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin

Eligibility

Criteria:

Inclusion Criteria: 1. 18 - 65 years of age 2. BMI 18 - 30 kg/m^2 3. Ability/willing to provide informed consent 4. Good general health Exclusion Criteria: 1. History of any pancreatic or biliary disease (eg. Familial colorectal cancer syndromes, Ulcerative colitis or Crohn's disease) 2. History of any acute or chronic illness that requires current medical therapy, including active gastrointestinal conditions, that might interfere with drug absorption 3. History of large bowel resection for any reason 4. Diagnosed narcotic or alcohol dependence 5. Women with childbearing potential who do not agree to practice effective birth control. 6. Use of curcumin within the last 14 days 7. Allergy to study agent 8. Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline. 9. Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin. 10. Women who are pregnant or nursing.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Gary N Asher, MD, MPH Principal Investigator UNC
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: UNC Department of Family Medicine
Location Countries

United States

Verification Date

2011-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: C3 tablet

Type: Active Comparator

Description: 4g C3 tablet

Label: Meriva

Type: Active Comparator

Description: 2g Meriva powder

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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