Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Blood concentration of piperine-curcuminoids
研究概览
简要总结
This pilot study aims to investigate the pharmacokinetics of a novel curcuminoid preparation with suggested high bioavailability due to its solubility in water, compared to two standard hydrophobic formulations. The findings of this study will help the health care providers and community to select suitable formulation.
详细描述
This pilot study is the first phase that must be followed, in the second phase, by longer clinical trials to support the findings and investigate the role of the novel preparation on health.The second phase will include an assessment of the effectiveness of several doses of curcumin preparation on health as well as an evaluation of the tolerance and possible adverse effects. The latter could not be evaluated at this stage of a single dose.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female Apparently healthy adults
排除标准
- •Postmenopausal women Smokers Overweight Chronic diseases
结局指标
主要结局
Blood concentration of piperine-curcuminoids
时间窗: [Time Frame: Change during 8 hours]
plasma piperine-curcuminoids levels using LC MS/MS
Blood concentration of hexahydrocurcumin
时间窗: [Time Frame: Change during 8 hours]
plasma hexahydrocurcumin levels using LC MS/MS
Blood concentration of curcumin diethyl disuccinate
时间窗: [Time Frame: Change during 8 hours]
plasma curcumin diethyl disuccinate levels using LC MS/MS
Blood concentration of curcumin
时间窗: [Time Frame: Change during 8 hours]
plasma curcumin levels using LC MS/MS
Blood concentration of desmethoxycurcumin
时间窗: [Time Frame: Change during 8 hours]
plasma desmethoxycurcumin levels using LC MS/MS
Blood concentration of bisdemethoxycurcumin
时间窗: [Time Frame: Change during 8 hours]
plasma bisdemethoxycurcumin levels using LC MS/MS
Blood concentration of tetrahydrocurcumin
时间窗: [Time Frame: Change during 8 hours]
plasma tetrahydrocurcumin levels using LC MS/MS
次要结局
未报告次要终点
研究者
Shatha Hammad, Assistant Professor
Assistant Professor
University of Jordan