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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Comparative Multidose Pharmacokinetics

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Outcome Measure:

AUC

Outcome Description:

Area under plasma concentration curve from 0-48h using 13 time points.

Outcome Time Frame:

0-48h

Safety Issue:

No

Principal Investigator

Gary N Asher, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC

Authority:

United States: Food and Drug Administration

Study ID:

10-2243

NCT ID:

NCT01330810

Start Date:

March 2011

Completion Date:

April 2012

Related Keywords:

  • Comparative Multidose Pharmacokinetics
  • Pharmacokinetics
  • Dietary Supplements
  • Curcumin

Name

Location

UNC Department of Family MedicineChapel Hill, North Carolina  27599