None listed
Conditions
Interventions
Intervention1: Actiserine - Phosphatidylserine Formulation (150 mg): a single dose will be administered orally, (as per randomization schedule) along with water, to the subjects in sitting posture - o
Sponsors
Shankar Nutricon Private Limited
Academy of Material Research
Eligibility
Inclusion criteria
Inclusion criteria: 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 Phosphatidylserine 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.
Exclusion criteria
Exclusion criteria: 1. Evidence of allergy or known hypersensitivity to Phosphatidylserine 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 Phosphatidylserine metabolism. 7. Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than 100 per 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 150 mg Phosphatidylserine daily within 2 weeks to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2.To monitor adverse event and to ensure safety of the subjects.Timepoint: At Screening and End of Study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. To monitor the adverse events and to ensure the safety of the subjects.Timepoint: before and after dosing of study product. | — |
Countries
India
Contacts
Public ContactShalini Dayananda
Unitree Healthcare and Diagnostics
Outcome results
None listed