A Double-Blind, Randomized, Single Dose, Two-Treatment, Two-Period, Two-Way Crossover, Oral Bioavailability Study of Investigational Product Containing Phosphatidylserine, 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
- 30
- 试验地点
- 1
- 主要终点
- 1. To evaluate the oral bioavailability of investigational product contains 150 mg of Phosphatidylserine of Molecules BioLabs Private Limited, and the reference product in healthy, adult, human subjects under fasting conditions.
研究概览
简要总结
Phosphatidylserine is an amino acid derivative that is fat soluble and found in high amounts in the brain. It protects nerve cells in the brain and enables them to communicate with each other. The nutritional supplement phosphatidylserine promotes cognitive function and memory. The amount of natural phosphatidylserine in body decreases as getting old. Phosphatidylserine is a type of phospholipid. It exists in your brain cell membranes, or the part of cell that protects the inside of the cell from the outside environment. Phosphatidylserine is believed to play a role in mood regulation, restorative sleep, and cognitive functions, such as attention, focus, processing speed, and memory. Phosphatidylserine is part of the cell structure in the body. The body can make phosphatidylserine, but most of what it needs comes from foods. It can also be taken as a supplement.Phosphatidylserine is a phospholipid nutrient found in fish, green leafy vegetables, soybeans and rice, and is essential for the normal functioning of neuronal cell membranes and activates Protein kinase C (PKC) which has been shown to be involved in memory function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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 .
- •Subject agrees avoid Phosphatidylserine containing medications and dietary supplements from screening until last visit.
- •Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit
- •Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 29 days of check in.
- •Subjects generally healthy as documented at screening considered by the physician or principal/clinical investigator.
- •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.
排除标准
- •Evidence of allergy or known hypersensitivity to Phosphatidylserine or other related drugs or other related drugs.
- •Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
- •Any major illness in the last three months or any significant ongoing chronic medical illness.
- •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.
- •History of alcohol addiction or abuse.
- •Malabsorption syndrome that affects Phosphatidylserine metabolism.
- •Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than 100 per min ventricular rate.
- •Gastrointestinal bleeding in past three months.
- •Uncontrolled diabetes mellitus.
- •Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness.
- •Psychopathic disorder, lack of cooperation.
- •Chronic obstructive lung disease or active smoking.
- •more than 2 cigarettes in the past 6 months.
- •Taking more than 150 mg Phosphatidylserine daily within 2 weeks to screening.
结局指标
主要结局
1. To evaluate the oral bioavailability of investigational product contains 150 mg of Phosphatidylserine of Molecules BioLabs Private Limited, and the reference product in healthy, adult, human subjects under fasting conditions.
时间窗: At Screening and End of Study visit.
2. To monitor adverse event and to ensure safety of the subjects.
时间窗: At Screening and End of Study visit.
次要结局
- 2. 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 Healthcare and Diagnostics