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.
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Shankar Nutricon Private Limited
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: At Screening and End of Study visit.
2. To monitor adverse event and to ensure safety of the subjects.
Time Frame: At Screening and End of Study visit.
Secondary Outcomes
- 2. To monitor the adverse events and to ensure the safety of the subjects.(before and after dosing of study product.)
Investigators
Dr Ambanna Gowda
Unitree Healthcare and Diagnostics