Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

Pharmacokinetics and Safety of a New Micellar Glutathione Formulation in Human Participants

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.

Inclusion Criteria:

• male or female aged 21-65 years
• healthy, good physical condition
• voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

• use of anti-inflammatory or non-steroidal anti-inflammatory drugs
• 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