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Curcumin Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01330810
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : August 3, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Comparative Multidose Pharmacokinetics Drug: curcumin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Crossover, Multiple Dose Pharmacokinetics of Two Curcumin Formulations in Healthy Volunteers
Study Start Date : March 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: C3 tablet
4g C3 tablet
Drug: curcumin
standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin

Active Comparator: Meriva
2g Meriva powder
Drug: curcumin
standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin

Primary Outcome Measures :
  1. AUC [ Time Frame: 0-48h ]
    Area under plasma concentration curve from 0-48h using 13 time points.

  2. Cmax [ Time Frame: 0-48h ]
    Maximum curcumin plasma concentration

  3. Tmax [ Time Frame: 0-48h ]
    Time to maximum curcumin plasma concentration

  4. Ke [ Time Frame: 0-48h ]
    Terminal elimination rate

  5. T1/2 [ Time Frame: 0-48h ]
    plasma curcumin concentration half-life

  6. Vd [ Time Frame: 0-48h ]
    Volume of distribution

  7. Test of bioequivalence [ Time Frame: 0-48h ]
    geometric mean ratio of plasma AUC0-48h of the two formulations

  8. bioequivalence of tissue curcumin concentration [ Time Frame: 1h ]
    comparison of curcumin concentration in colorectal tissue at single time point between two formulations

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01330810

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United States, North Carolina
UNC Department of Family Medicine
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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Principal Investigator: Gary N Asher, MD, MPH UNC
Publications of Results:
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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01330810    
Other Study ID Numbers: 10-2243
First Posted: April 7, 2011    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: December 2011
Keywords provided by University of North Carolina, Chapel Hill:
Dietary Supplements
Additional relevant MeSH terms:
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Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action