NCT06345950

Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Factors Group of Nutritional Companies Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Bioavailability Heathy Volunteers
• Safety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Liposomal Glutathione	A maximum single dose of 300 mg glutathione (hard gel capsules)
DIETARY_SUPPLEMENT	Standard Glutathione	A maximum single dose of 500 mg glutathione (hard gel capsules)
DIETARY_SUPPLEMENT	New Micellar Glutathione (Lipomicel)	A maximum single dose of 300 mg glutathione (soft gel capsules)

Timeline

• Start date: 2022-06-21
• Primary completion: 2025-06-30
• Completion: 2025-12-30
• First posted: 2024-04-03
• Last updated: 2026-02-27

Locations

1 site across 1 country: Canada