An open label, single arm, pilot study to determine the bioavailability of Liposomal CoQ-10 in three (3 no) healthy human volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To determine the bioavailability of CoQ-10 in liposomal CoQ-10 formulations
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.
After obtaining the Ethics committee approval subjects will be asked to visit the site. After taking a written informed consent from the healthy subject’s, they will be asked about their medical history and the Investigator or his/her designee will conduct a physical examination. Demographics and vital signs will be recorded. Blood sample will be drawn from each subject for analysis of haematology, biochemistry and virology. X-ray and ECG will be performed.
Subjects will be enrolled into the study after all the IC/EC criteria are met.
They will be asked to report to the site after 7 days. They will be in-housed into the facility. Physical examination will be conducted. Vitals will be recorded. They will be asked for overnight fasting for at least 10 hours
On the day of dosing, physical examination along will be performed. Vitals will be recorded. An indwelling IV cannula/scalp vein will be placed in-situ on a forearm vein of the subjects till 12 hours. Blood samples will be drawn for pharmacokinetic analysis on these time period 0hrs will be before the dosing. Vitals will be recorded at this time along with physical examination.
On the day of the study, phlebotomy will be performed within 01 hours prior to dosing. An indwelling IV cannula/scalp vein will be placed in-situ of a forearm vein of the subjects till 12 hours. Subsequent samples after 12.00 hrs. will be drawn by fresh direct venipuncture. After dosing these will be the time points of blood sampling, 0min, 30min, 60min, 90min, 120min, 3hr, 4hr, 6hr, 8hr, 12 hr and 24hrs.
Vitals will be recorded at these time points, 0min, 30min, 60min, 90min, 120min, 3hr, 4hr, 6hr, 8hr, 12 hr and post-dose and at the time of checkout (24.00 hrs).
The subject will be allowed to leave the facility after 24 hrs of dosing. Physical examination along with Vitals will be performed. Blood sample will be drawn for analysis of hematology and biochemistry. The subject will leave the facility after all the procedures have been conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects must be healthy human male and female (non-pregnant) subjects.
- •2.Age should be between 18-45 years of age (both inclusive), weighing at least 50 kg.
- •3.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.
- •4.Subjects with no evidence of underlying disease during the pre-study screening.
- •5.Subjects whose screening laboratory values are within normal limits or considered by the physician or Principal Investigator to be of no clinical significance.
排除标准
- •1.Subjects who are allergic to CoQ-10 products or any food or other drugs.
- •2.Subjects who had taken drugs to reduce fat or statins in the last month.
- •3.Subject with resting hypotension (BP less than 90 to 60) or hypertension (BP greater than 140 to 90) and pulse rate below 50 per min and more than 100 per min.
- •4.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.
- •5.Subjects with a history of MI, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Asthma, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •6.Subjects who have taken over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study.
- •7.Subject who has a history of alcoholism, drug abuse or Smoking.
- •8.Subjects who are hypersensitive to Heparin.
- •9.Subjects who participated in any other clinical study in the past three months.
- •10.Subject with clinically significant abnormal lab values, abnormal ECG , abnormal Chest X-ray (PA View).
- •11.Subject who has difficulty with donating blood.
- •12.Subject with history of difficulty in swallowing.
- •13.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 CoQ-10 formulations
时间窗: 0min, 30min, 60min, 90min, 120min, 3hr, 4hr, 6hr, 8hr, 12 hr and 24hrs.
次要结局
- The secondary objective of this study is to monitor the safety and tolerability of a single dose of liposomal CoQ-10 formulations.(Day 0 and Day 1)
研究者
Dr Ashok Godavarthi
Radiant Research Services Pvt. Ltd