Pharmacokinetics of Different CoQ10 Formulations - a Randomized, Double-blind, Single-dose, Crossover Study on the Bioavailability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Tmax: (the time point of maximum plasma concentration) of orally ingested CoQ10 in different formulations and determine the ratio of reduced CoQ10 levels to total CoQ10 concentrations in healthy adults.
研究概览
简要总结
The objective of this trial is to compare the bioavailability (AUC, Tmax, and Cmax) of different Coenzyme Q10 preparations in healthy adults. Pharmacokinetic parameters of orally ingested CoQ10 such as AUC, Cmax and Tmax, as well as the ratio of reduced CoQ10 levels to total CoQ10 plasma levels (using the AUC) after administration are compared.
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
- •Participants are required to meet the following criteria to be eligible for enrollment: male or female aged 21-65 years or older
- •Participants must complete an online health questionnaire on their medical history (pregnancy must be excluded) upon study enrolment.
- •Voluntary, written, informed consent to participate in the study.
排除标准
- •Unstable medical condition; use of any acute medications during study period.
- •Use of Coumadin Warfarin; use of supplements containing Coenzyme Q10, including the intake of any other supplements within 2 weeks of the beginning of the study (except for vitamin D and calcium). The use of any supplements except for vitamin D and calcium, are prohibited for the duration of the study.
- •History of serious acute or chronic diseases such as gastrointestinal disorders, liver-, kidney-, cardiovascular, or hematological disease or diabetes; or other diseases; intolerances or food allergies such as gluten (in terms of the standardized meals).
- •Using any form of nicotine or tobacco; participation in another investigational study
结局指标
主要结局
Tmax: (the time point of maximum plasma concentration) of orally ingested CoQ10 in different formulations and determine the ratio of reduced CoQ10 levels to total CoQ10 concentrations in healthy adults.
时间窗: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Cmax: (maximum plasma concentration) To evaluate the peak concentrations of orally ingested CoQ10 in different formulations and determine the ratio of reduced CoQ10 levels to total CoQ10 concentrations in healthy adults.
时间窗: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
AUC: (the area under the concentration-time curve) to evaluate the absorption of orally ingested CoQ10 in different formulations and determine the ratio of reduced CoQ10 levels to total CoQ10 concentrations in healthy adults.
时间窗: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours
Blood concentrations of reduced and total CoQ10 are analyzed by ultra-performance liquid chromatography (UHPLC) coupled to a Thermo QExactive Orbitrap Mass Spectrometer.
次要结局
未报告次要终点