Novel Micellar Formulation of Silymarin with Enhanced Bioavailability in a Double-Blind, Randomized, Crossover Human Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- AUC: the area under the concentration-time curve
研究概览
简要总结
This study seeks to evaluate and compare the pharmacokinetics of a novel micellar silymarin formulation with that of a standard silymarin formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 21- 65 years
- •Healthy, good physical condition
- •Voluntary, written, informed consent to participate in the study.
排除标准
- •Serious acute or chronic diseases e.g. liver, kidney, or gastrointestinal diseases
- •Contraindication or allergies to milk thistle
- •Pregnancy or breastfeeding
- •Concurrent use of supplements and/or medications
- •Participation in another investigational study
结局指标
主要结局
AUC: the area under the concentration-time curve
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing silymarin.
Cmax: maximum plasma concentration
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing silymarin.
Tmax: the time point of maximum plasma concentration
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing silymarin.
MRT: Mean residence time
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the mean residence time (MRT) with that of other capsules containing silymarin.
T1/2: elimination half-life
时间窗: 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)
To determine the gastrointestinal absorption of orally ingested silymarin in healthy adult volunteers and compare the elimination half-life (T1/2) with that of other capsules containing silymarin.
次要结局
未报告次要终点