None listed
Conditions
Interventions
Intervention1: Powder form of Liposomal Glutathione formulation.: 2capsules to be taken orally with water once.
Intervention2: Liquid form of Liposomal Glutathione formulation: 10ml to be taken with w
Sponsors
Molecules BioLabs Pvt Ltd,
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 per m2 to 24.99 kg per m2 2. Subject agrees avoid Glutathione 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.
Exclusion criteria
Exclusion criteria: 1. Evidence of allergy or known hypersensitivity to Glutathione 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 Glutathione 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 500 mg Glutathione daily within 2 weeks to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the oral bioavailability of investigational product (650 mg capsule containing NLT 500 mg of Glutathione / Capsule for T1 and NLT 500 mg of Glutathione/ 10 mL Bottle for T2) of Molecules BioLabs Private Limited, and the reference product (650 mg capsules which contains NLT 500 mg of conventional Glutathione) of Molecules BioLabs Private Limited in healthy, adult, human subjects under fasting conditions.Timepoint: Day 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. To monitor the adverse events and to ensure the safety of the subjects.Timepoint: Day1 and End of Study. | — |
Countries
India
Contacts
Public ContactShalini Dayananda
Unitree Health Care Diagnostics
Outcome results
None listed