None listed
Conditions
Interventions
Intervention1: Test Product (T1)- Powder form of Liposomal Quercetin formulation: 1 capsule to be consumed once on day1.
Intervention2: Test Product (T2)- Liquid form of Liposomal Quercetin formulati
Sponsors
Molecules Biolabs Private Limited
Eligibility
Inclusion criteria
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 (according to the formula of BMI = weight (kg) / [height (m)]2 ). Subject agrees avoid Quercetin 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. Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months. Willing to consume ova-lacto vegetarian diet. Willing to comply to all requirements of this study protocol as well as instructed by the study personnel 9. 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: Evidence of allergy or known hypersensitivity to Quercetin 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 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 Quercetin metabolism. 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 100 mg Quercetin daily within 2 weeks to screening. Consumption of caffeine and /or Xanthine containing products(i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study. Consumption of grapefruit and its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study. Female subjects demonstrating a positive pregnancy at screening. Female subjects who are currently lactating, likely to become pregnant during conducting of the study, Using of hormone replacement therapy for a Period of 06 months prior to dosing and Using any oral contraceptives including estrogen and progesterone combined.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the oral bioavailability of investigational product (1capsule containing 100 mg of Quercetin/ Capsule for Test 1 & Test 2 & Reference) of Molecules BioLabs Private Limited, in healthy, adult, human subjects under fasting conditions.Timepoint: Day 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety of the subjects.Timepoint: Day1 through End of study. | — |
Countries
India
Contacts
Public ContactShalini Dayananda
Unitree Health Care Diagnostics
Outcome results
None listed