Bioavailability Study of COQUN ORAL FORMULATION (CoQ10) Administered in Healthy Adults (CoQ10-01)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Analysis of Pharmacokinetic Property "Area Under the Curve"
研究概览
简要总结
The goal of the study is to evaluate the best dosage for COQUN ORAL FORMULATION in order to reach a level of plasma concentration which might assure its antioxidant effect if taken on a regular basis.
详细描述
The study will include 24 healthy subjects who will test the CoQ10 formulation. All 24 subjects will test a single dose of 100mg CoQ10 in 1 day to assess bioavailability, which will be followed by a one week wash-out period and then by a 4 week period of continuous administration of COQUN ORAL FORMULATION in parallel groups (1:1): patients will be divided in the continuous treatment period into two groups, one group of 12 patients with intake of 100mg OD, the other one group of 12 patients with intake of 100mg BID, in order to assess multiple-dose profile of COQUN ORAL FORMULATION.
Patients will have to fast the night before enrolment, for at least 10 hours. Patients will be requested to fill in a short diary in the multidose phase, on a daily basis, for confirming the product correct intake, and informing on any experienced adverse event and eventual medication taken for its solving.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject Informed consent form (ICF) is signed
- •M & F Aged between 35-75 years at the time of the signature of ICF
- •A body mass index between 20 and 29 kg/m2
- •Fasting the night before enrolment, for at least 10 hours
- •Healthy, meaning absence of any prescribed medication for a month prior to the inclusion to the study and during the study
- •Willing to avoid a consumption of any food supplements except vitamin D and calcium at least 2 weeks before and during the study
- •Consumption of dairy and cereal products (standardized breakfast will include low lactose dairy and bread)
- •Willing to follow all study procedures, including attending all site visits (including sessions during which a venous line will be inserted for blood sampling), and keeping a diary for the time of multiple-dose study (to follow their compliance and palatability)
排除标准
- •Intake of any prescribed medication within 2 weeks of the beginning of the study
- •Intake of any food supplements within 2 weeks of the beginning of the study, except vitamin D and calcium
- •Hypotension
- •Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or hematological disease, diabetes
- •Gastrointestinal disorders or other serious acute or chronic diseases
- •Known lactose/gluten intolerances/ food allergies (limitation for standardization of meals)
- •Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
- •Known drug and/or alcohol abuse
- •Using any form of nicotine or tobacco
- •Mental incapacity that precludes adequate understanding or cooperation
- •Participation in another investigational study or blood donation within 3 months prior to or during this study
研究组 & 干预措施
Group A
100 mg OD
干预措施: COQUN ORAL FORMULATION (Dietary Supplement)
Group B
100 mg BID
干预措施: COQUN ORAL FORMULATION (Dietary Supplement)
结局指标
主要结局
Analysis of Pharmacokinetic Property "Area Under the Curve"
时间窗: from day-7 to day 28
- Area under the curve (microg/ml x h): ≥5 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided. Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.
Analysis of Pharmacokinetic Property "Cmax"
时间窗: from day-7 to day 28
- Cmax: ≥0,8 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided. Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.
Analysis of Pharmacokinetic Property "Tmax"
时间窗: from day-7 to day 28
- Tmax: ≥3 Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided. Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit.
次要结局
未报告次要终点