NCT06736366已完成不适用
Comparative Single-dose Bioavailability Clinical Study of Two Different Coenzyme Q10 Products
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Plasma levels of Coenzyme Q10
研究概览
简要总结
The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products
详细描述
The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products will include 35 subjects who will test two different coenzyme Q10 products. Plasma concentration of coenzyme Q10 will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subject informed consent form
- •aged between 50 and 65 years old
- •body mass for women 70± 5 kg and for men 85± 5 kg
- •non-smoking
- •healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases
- •absence of any prescribed medication during the study
- •willing to avoid a consumption of any food supplements at least 2 weeks before and during the study
排除标准
- •cardio-vascular diseases, diabetes, neurodegenerative diseases, gastrointestinal disorders, pregnancy, breast-feeding
- •intake of any food supplements within two week of the beginning of the study
- •drug or alcohol abuse
结局指标
主要结局
Plasma levels of Coenzyme Q10
时间窗: Forthy-eight hours after consumption
Plasma levels of Coenzyme Q10 will be measured by high-performance liquid chromatography (HPLC) with electrochemical detection and a post-analytical reducing column, using a Nanospace HPLC apparatus.
次要结局
未报告次要终点
研究者
Zala Jenko Praznikar
Associate Professor, PhD
University of Primorska
研究点 (2)
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