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Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

NCT06345950 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-02-27

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Isura

    collaborator OTHER

  • Factors Group of Nutritional Companies Inc.

    lead INDUSTRY

Principal Investigators

  • Julia Solnier, PhD · Isura

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2025-06-30
Completion
2025-12-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06345950 on ClinicalTrials.gov