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临床试验/NCT01330810
NCT01330810已完成1 期

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

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Cmax

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 - 65 years of age
  • BMI 18 - 30 kg/m^2
  • Ability/willing to provide informed consent
  • Good general health

排除标准

  • History of any pancreatic or biliary disease (eg. Familial colorectal cancer syndromes, Ulcerative colitis or Crohn's disease)
  • History of any acute or chronic illness that requires current medical therapy, including active gastrointestinal conditions, that might interfere with drug absorption
  • History of large bowel resection for any reason
  • Diagnosed narcotic or alcohol dependence
  • Women with childbearing potential who do not agree to practice effective birth control.
  • Use of curcumin within the last 14 days
  • Allergy to study agent
  • Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline.
  • Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin.
  • Women who are pregnant or nursing.

研究组 & 干预措施

C3 tablet

Active Comparator

4g C3 tablet

干预措施: curcumin (Drug)

Meriva

Active Comparator

2g Meriva powder

干预措施: curcumin (Drug)

结局指标

主要结局

Cmax

时间窗: 0-48h

Maximum curcumin plasma concentration

AUC

时间窗: 0-48h

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

Ke

时间窗: 0-48h

Terminal elimination rate

T1/2

时间窗: 0-48h

plasma curcumin concentration half-life

Tmax

时间窗: 0-48h

Time to maximum curcumin plasma concentration

Test of bioequivalence

时间窗: 0-48h

geometric mean ratio of plasma AUC0-48h of the two formulations

Vd

时间窗: 0-48h

Volume of distribution

bioequivalence of tissue curcumin concentration

时间窗: 1h

comparison of curcumin concentration in colorectal tissue at single time point between two formulations

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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