Pharmacokinetics and Safety of a New Micellar Glutathione Formulation
NCT ID: NCT06345950
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
16 participants
INTERVENTIONAL
2022-06-21
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacological Profile of Different Quercetin Formulations
NCT05611827
Safety and Pharmacokinetics of Nicotinamide Mononucleotide (NMN) in Healthy Adults.
NCT04910061
A Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Dosing of GS-248
NCT04617509
Pharmacokinetics of MCS in Healthy Volunteers
NCT01003171
Impact of Metformin and Polysorbate 80 on Drug Absorption and Disposition
NCT04640571
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Liposomal Glutathione
Each participant receives their treatment i.e., Liposomal Glutathione hard gel capsules at a total dose of 500 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose.
A washout period of at least 14 days between each treatment is used.
Liposomal Glutathione
A maximum single dose of 500 mg glutathione (hard gel capsules)
Standard Glutathione
Each participant receives their treatment i.e., Standard Glutathione hard gel capsules at a total dose of 500 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose.
A washout period of at least 14 days between each treatment is used.
Standard Glutathione
A maximum single dose of 500 mg glutathione (hard gel capsules)
New Micellar Glutathione (Lipomicel)
Each participant receives their treatment i.e., LipoMicel Glutathione soft gel capsules at a total dose of 600 mg glutathione. Treatments are consumed with a glass of water (approx. 125mL), followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose.
A washout period of at least 14 days between each treatment is used.
New Micellar Glutathione (Lipomicel)
A maximum single dose of 600 mg glutathione (soft gel capsules)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Liposomal Glutathione
A maximum single dose of 500 mg glutathione (hard gel capsules)
Standard Glutathione
A maximum single dose of 500 mg glutathione (hard gel capsules)
New Micellar Glutathione (Lipomicel)
A maximum single dose of 600 mg glutathione (soft gel capsules)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* healthy, good physical condition
* voluntary, written, informed consent to participate in the study.
Exclusion Criteria
* previous history of cardiovascular disease or acute or chronic inflammatory disease
* use of antioxidant supplements or cholesterol-lowering agents
* change of diet habits or lifestyle (diet, physical activity, etc.)
* alcohol or substance abuse history
* use of nicotine or tobacco
* participation in another investigational study
21 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Isura
OTHER
Factors Group of Nutritional Companies Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julia Solnier, PhD
Role: PRINCIPAL_INVESTIGATOR
Isura
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ISURA
Burnaby, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-04-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.