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Trial record 23 of 158 for:    Enzyme | curcumin

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

Tracking Information
First Submitted Date  ICMJE April 4, 2011
First Posted Date  ICMJE April 7, 2011
Last Update Posted Date August 3, 2017
Study Start Date  ICMJE March 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2011)
  • AUC [ Time Frame: 0-48h ]
    Area under plasma concentration curve from 0-48h using 13 time points.
  • Cmax [ Time Frame: 0-48h ]
    Maximum curcumin plasma concentration
  • Tmax [ Time Frame: 0-48h ]
    Time to maximum curcumin plasma concentration
  • Ke [ Time Frame: 0-48h ]
    Terminal elimination rate
  • T1/2 [ Time Frame: 0-48h ]
    plasma curcumin concentration half-life
  • Vd [ Time Frame: 0-48h ]
    Volume of distribution
  • Test of bioequivalence [ Time Frame: 0-48h ]
    geometric mean ratio of plasma AUC0-48h of the two formulations
  • bioequivalence of tissue curcumin concentration [ Time Frame: 1h ]
    comparison of curcumin concentration in colorectal tissue at single time point between two formulations
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01330810 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Curcumin Pharmacokinetics
Official Title  ICMJE Crossover, Multiple Dose Pharmacokinetics of Two Curcumin Formulations in Healthy Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Comparative Multidose Pharmacokinetics
Intervention  ICMJE Drug: curcumin
standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin
Study Arms  ICMJE
  • Active Comparator: C3 tablet
    4g C3 tablet
    Intervention: Drug: curcumin
  • Active Comparator: Meriva
    2g Meriva powder
    Intervention: Drug: curcumin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2011)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01330810
Other Study ID Numbers  ICMJE 10-2243
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gary N Asher, MD, MPH UNC
PRS Account University of North Carolina, Chapel Hill
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP