A randomized, double blind, placebo controlled, three arm, cross-over trial to assess the bioavailability of liposomal and non-liposomal CoQ-10 formulations in plasma in healthy volunteers
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To determine the bioavailability of CoQ-10 in liposomal and non-liposomal formulations in plasma by LCMS/HPLC
研究概览
简要总结
Liposomal CoQ-10 is basically CoQ-10 in a liposome. Coenzyme Q10 (CoQ-10), ubiquinone, is an endogenous lipophilic benzoquinone compound which acts as an electron transport in the respiratory chain of the mammalian mitochondrial membrane. Over the last few years, CoQ-10 gained significant research attention as a dietary supplement used for generating cellular bioenergy and preventing tissue damage caused by oxidative stress. 1 However, only a very small percentage of orally administered crystalline CoQ-10 is taken up in the blood stream, making the treatment of CoQ10 deficiencies difficult. Due to the hydrophobic nature of CoQ-10, the use of a liposomal carrier for the delivery might be possible. Since CoQ-10 is largely located in the inner mitochondrial membrane, a mitochondrial-targeted delivery system will be needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must be healthy human male and female (non-pregnant) subjects.
- •Age should be between 18-45 years of age (both inclusive), weighing at least 50 kg.
- •Subject who are ready to provide written informed consent and should be willing to be available throughout the study duration and should follow the guidelines mentioned in the protocol.
- •Subjects with no evidence of underlying disease during the pre-study screening.
- •They must be healthy as determined by medical history and physical examination, ECG, Chest X-ray (PA View) and laboratory tests performed within 7 days prior to the commencement of the study.
- •Subjects whose screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
排除标准
- •Subjects who are allergic to CoQ 10 products or any food or other drugs.
- •Subjects who had taken drugs to reduce fat or statins or vitamin supplements (including vitamin E) during the last month.
- •Subject with resting hypotension (BP 140 /90) and pulse rate below 50/min and more than 100/min.
- •Subject with or a prior history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, musculoskeletal or psychiatric disease or who has been hospitalized or underwent surgery within the last 4 weeks prior to in-housing.
- •Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study.
- •Subject who has a history of alcoholism, drug abuse or Smoking.
- •Subjects who are hypersensitive to Heparin
- •Subjects who participated in any other clinical study in the past three months.
- •Subject with clinically significant abnormal lab values/ abnormal ECG / abnormal Chest X ray (PA View).
- •Subject who has difficulty with donating blood.
- •Subject with history of difficulty in swallowing.
- •Subject who has unsuitable veins for repeated venipuncture.
结局指标
主要结局
To determine the bioavailability of CoQ-10 in liposomal and non-liposomal formulations in plasma by LCMS/HPLC
时间窗: 0min, 30min, 60min, | 90min, 120min, 3hr, 4hr, 6hr, 8hr, 12hr and 24hrs for period 1,2 and 3
次要结局
- 1. To evaluate the changes in biomarkers – CRP, MDA,(Serum anti-oxidant capacity (Glutathione Peroxidase-1,)
研究者
Dr Ashok Godavarthi
Radiant research services pvt. Ltd