None listed
Conditions
Interventions
Intervention1: F-GSH: 1000 mg,Capsule, Single day, single-dose oral administration of F-GSH
Control Intervention1: UF-GSH: 1000 mg,Capsule, Single day, single-dose oral administration of UF-GSH
Sponsors
Akay Natural Ingredients Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 2.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects who have consumed either glutathione (GSH) containing food/supplement 7 days prior to screening.2.Pregnant or lactating women.3.Subjects with known hypersensitivity to the investigational products.4.Subjects who have participated in any clinical trial in the past 1 month.5.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study.6.Any other condition that in the opinion of the investigator that does not justify the subject’s participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the concentrations of formulated Glutathione (F-GSH) in comparison with normal unformulated Glutathione (UF-GSH) supplementationTimepoint: Baseline, Day 1 and Day 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters of F-GSH in comparison with UF-GSH supplementationTimepoint: Baseline, Day 1 and Day 9;Safety and tolerability of F-GSH in comparison with UF-GSH supplementation.Timepoint: Baseline, Day 1 and Day 9 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed