An Open-label, randomized, single dose, three-treatment, three-period, three-way crossover, oral bioavailability study of investigational product containing Coenzyme Q10 (CoQ10), in healthy, adult, human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 1. To evaluate the oral bioavailability of investigational product (400 mg capsule containing NLT 100 mg of CoQ10/ Capsule for T1 and NLT 100 mg of CoQ10/ 10 mL Sachet for T2) of Molecules BioLabs Private Limited, and the reference product (400 mg capsules which contains NLT 100 mg of conventional CoQ10) of Molecules BioLabs Private Limited in healthy, adult, human subjects under fasting conditions.
研究概览
简要总结
Coenzyme Q10 (CoQ10), also known as ubiquinone, is a fat-soluble, vitamin-like substance that resembles a vitamin E molecule. It is found in the inner membrane of mitochondria, where it participates in the electron transport chain- a series of reactions that generate adenosine triphosphate (ATP), the molecule that fuels cellular processes.Coenzyme Q10, often abbreviated as CoQ10, is a vital antioxidant and nutrient that plays a crucial role in generating energy in the cells. It is acts as an antioxidant, helping to neutralize free radicals and reduce oxidative stress in cells. Moreover, it plays a crucial role in maintaining cellular membrane integrity and in the production of energy in the form of ATP within cells, particularly in organs that require a lot of energy, such as the heart, liver, and kidneys.
CoQ10 is also available as a dietary supplement and is believed to have various health benefits, such as supporting heart health, promoting energy production, and acting as an antioxidant to protect cells from damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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.Normal, healthy, adult, male and female Human participants of age between 18-45 years with a Body Mass Index (BMI) range between 18.50 kg/m2 to 24.99 kg/m2 2.Subject agrees avoid CoQ10 containing medications and dietary supplements from screening until last visit.
- •3.Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit.
- •4.Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 29 days of check in.
- •5.Subjects generally healthy as documented at screening considered by the physician or principal/clinical investigator.
- •6.Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
- •7.Non- smokers or ex-smokers.
- •Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
- •8.Willing to consume ova-lacto vegetarian diet.
- •9.Willing to comply to all requirements of this study protocol as well as instructed by the study personnel 10.Generally healthy as documented by gynecological examination and breast examination (for female subjects during Period-I check-in only).
- •11.Female subjects of childbearing potential; a.Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator; and/or b.Surgically sterile (bilateral tubal ligation).
排除标准
- •1.Evidence of allergy or known hypersensitivity to CoQ10 or other related drugs or other related drugs.
- •2.Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
- •3.Any major illness in the last three months or any significant ongoing chronic medical illness.
- •4.Any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •5.History of alcohol addiction or abuse.
- •6.Malabsorption syndrome that affects CoQ10 metabolism.
- •7.Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than100/min ventricular rate.
- •8.Gastrointestinal bleeding in past three months.
- •9.Uncontrolled diabetes mellitus.
- •10.Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness.
- •11.Psychopathic disorder, lack of cooperation.
- •12.Chronic obstructive lung disease or active smoking (more than 2 cigarettes in the past 6 months) 13.Taking more than 100 mg CoQ10 daily within 2 weeks to screening.
结局指标
主要结局
1. To evaluate the oral bioavailability of investigational product (400 mg capsule containing NLT 100 mg of CoQ10/ Capsule for T1 and NLT 100 mg of CoQ10/ 10 mL Sachet for T2) of Molecules BioLabs Private Limited, and the reference product (400 mg capsules which contains NLT 100 mg of conventional CoQ10) of Molecules BioLabs Private Limited in healthy, adult, human subjects under fasting conditions.
时间窗: before and after dosing of study product.
次要结局
- To monitor the adverse events and to ensure the safety of the subjects.(before and after dosing of study product.)
研究者
Dr Ambanna Gowda
Unitree Health Care Diagnostics