protocolSection identificationModule nctId: NCT06345950, orgStudyIdInfo id: 2022-04-003, briefTitle: Pharmacokinetics and Safety of a New Micellar Glutathione Formulation, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-21, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Factors Group of Nutritional Companies Inc., class: INDUSTRY, collaborators name: Isura, descriptionModule briefSummary: This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers.The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period., conditionsModule conditions: Bioavailability, conditions: Safety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of one intervention with higher bioavailability is evaluated in an additional single-arm, 30-day trial., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: Liposomal Glutathione, interventions name: Standard Glutathione, interventions name: New Micellar Glutathione (Lipomicel), outcomesModule primaryOutcomes measure: AUC: the area under the concentration-time curve, primaryOutcomes measure: Cmax: maximum plasma concentration, primaryOutcomes measure: Tmax: the time point of maximum plasma concentration, secondaryOutcomes measure: Alanine aminotransferase (ALT), secondaryOutcomes measure: Aspartate aminotransferase (AST), secondaryOutcomes measure: Alkaline phosphatase (ALP), secondaryOutcomes measure: Bilirubin, secondaryOutcomes measure: Serum creatinine, secondaryOutcomes measure: Blood urea nitrogen (BUN), secondaryOutcomes measure: Glomerular filtration rate (GFR), secondaryOutcomes measure: C-reactive protein (CRP), secondaryOutcomes measure: White blood cell count (WBC), secondaryOutcomes measure: Hemoglobin (Hb), secondaryOutcomes measure: Hematocrit (Hct), secondaryOutcomes measure: Platelet count, secondaryOutcomes measure: Fasting blood glucose, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Low-density lipoprotein (LDL) cholesterol, secondaryOutcomes measure: High-density lipoprotein (HDL) cholesterol, secondaryOutcomes measure: Triglycerides, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ISURA, city: Burnaby, state: British Columbia, zip: V2N 4S9, country: Canada, geoPoint lat: 49.26636, lon: -122.95263, hasResults: False