NCT04028739已完成不适用
A Randomized, Open-label, Cross-over, Single Administration Study to Compare Bioavailability of Curcumin in Health Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A randomized, open-label, cross-over, single administration study to compare bioavailability of curcumin in health adults
详细描述
- Randomization, Open-label, 3-period, 6-sequence, Crossover, Single
- Drug-free inverval : more than 7 days
- Sampling time : 0,0.5,1,1.5,2,3,4,6,8,12h
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult 19 to 60 years
- •BMI 18.0~30.0kg/m2 at screening
- •Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.
排除标准
- •A person with clinically significant disease corresponding to cardiovascular, respiratory, liver, kidney, digestive system, blood/tumor system, endocrine system, immune system, neuropsychiatry or who has a history within the last 6 months.
- •A person with a history of gastrointestinal disease or surgery (except for simple cecal surgery or hernia surgery) that may affect the absorption of food for clinical research.
- •Persons who have an irritable reaction to foods containing turmeric or other drugs and food.
- •Those who took medicines within 7 days before the first intake of food for clinical research.
- •Food for Clinical Research If you have consumed foods containing turmeric (eg, radishes, curry) within 7 days before the first intake of food, or you can't consume until the day of intake of food for the last clinical study.
- •Those who have participated in other clinical studies within 90 days prior to the first intake of food for clinical research.
- •Women who are pregnant or lactating during screening, or who plan to become pregnant during clinical research. A person who is deemed unsuitable for participating in this clinical study because of other reasons.
研究组 & 干预措施
Theracurmin CR-033P
Experimental
1 Capsule with 150mL water, Single, curcumin 90mg/day
干预措施: curmin (Dietary Supplement)
Theracurmin CR-031P
Experimental
3 Capsule with 150mL water, Single, curcumin 90mg/day
干预措施: curmin (Dietary Supplement)
Curcumin
Experimental
1 Capsule with 150mL water, Single, curcumin 90mg/day
干预措施: curmin (Dietary Supplement)
结局指标
主要结局
Cmax
时间窗: 12hours
Maximum concentration at steady state
AUC
时间窗: 12hours
Area under the concentration-time curve at steady state
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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