Crossover, Multiple Dose Pharmacokinetics of Two Curcumin Formulations in Healthy Volunteers
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
- 是
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
4g C3 tablet
干预措施: curcumin (Drug)
Meriva
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
