None listed
Conditions
Interventions
Intervention1: Glutathione loaded in Zeal platform : Dose: 500 mg one capsule Frequency Dose range: 250-1000 mg/day
Intervention2: Glutathione loaded in Zeal platform : Dose: 500 mg one capsule Freq
Sponsors
Aurea Biolabs (P) Limited.
IR Innovate Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject should provide written informed consent. 2. Subject must be a healthy adult within 25.00-50.00 years of age (both inclusive). 3. Subject should have a Body Mass Index of 18.50 kg/m2 and 29.99 kg/m2 (Both Inclusive). 4. Subject should have within the normal range or not clinically significant for Hematology, chemistry and urinalysis. 5.Subject must be of normal health as determined by medical and surgical history and physical examination performed within 21 days prior to the dosing of Period. 6. Subject should have normal ECG and vital signs. 7. Subject who is Non-smoker. 8. Availability of a study volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 9. Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody and Syphilis. 10. Negative urine test for drug of abuse for morphine, barbiturates, benzodiazepines, amphetamine, THC & cocaine (to be performed on the day of check-in during each period). 11. Negative Urine test for alcohol consumption (to be performed on the day of check-in during each period).
Exclusion criteria
Exclusion criteria: 1. Personal or family history of skin cancer, especially melanoma 2. Consumption of any preparations containing glutathione within 1 month of enrollment 3. Use of any topical skin brightening or whitening preparations containing glutathione within 1 month of enrollment 4. A pregnant or breastfeeding mother 5. Personal history of food ingredient allergy or skin disorder due to side effects of oral therapy 6. Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment. 7. Subject has a history of alcohol, smoking or other food ingredient abuse in the past year. 8. Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP 140 and/or diastolic BP 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease. 9. Subject has a known allergy or sensitivity to any ingredient in the test product 10. Subject has any medical condition or uses any food ingredient, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk. 11. Subject has a history of difficulty swallowing large pills or tablets. 12. Investigator is uncertain about subject s capability or willingness to comply with the protocol requirements 13. Subject is incapable of understanding the informed consent. 14. Investigator is uncertain about subject s capability or willingness to comply with the protocol requirements. 15. Intake of any prescription food ingredients within 14 days prior to check-in and throughout the study, and/or over-the counter (OTC) & herbal food ingredients, CYP3A4 inhibitors/ alpha-blockers/ Food ingredients Metabolized by CYP2D6/ digoxin & warfarin within 7 days prior to check-in and / or intake of any food ingredient in the past for long term that could affect the kinetics or dynamics of study food ingredients in view of investigator. 16. Subject has a history of any psychiatric illness, which may impair the ability to provide written, informed consent. 17. Alcohol consumers, intake of alcohol 07 days prior to check-in and/or found positive in Urine test for alcohol consumption during check-in of each period. 18. Consumption of grapefruit juice and /or grapefruit at least 72.00 hours prior to period I check-in through the last PK sample collection of the last period of the study. 19. History of habituation to or consumption of caffeine and /or xanthine products, and tobacco containing products within 72.00 hours prior to check-in and inability to withhold the intake during the in house stay. 20. Subject has clinically significant abnormal values of laboratory parameters. 21. Subject has participated in any other clinical investigation using experimental food ingredient or had bled more than 350 mL in the past 90 days. 22. Subject is unable to or unlikely to be compliant with protocol requirements or restrictions. 23. Subject, in whom study food ingredient is contraindicated for medical reasons 24. Subject is intolerant to venipuncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure and compare the pharmacokinetics of Test with reference under fasting condition in healthy, adult, human subjects in a randomized cross over study.Timepoint: Sampling time points: Pre-dose at 0.00 and 01.00, 02.00, 04.00, 06.00, 12.00, 18.00 and 24.00 hours post-dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Renal Function Test and Liver Function Test.Timepoint: Sampling points: 00.00, 1.00, 2.00, 4.00, 6.00, 12.00, 18.00 and 24.00 hours post-dose. | — |
Countries
India
Contacts
Public ContactDr K Sudhakar Reddy
IndiGlobal Labs Private Limited
Outcome results
None listed