A Human Study on the Pharmacokinetic Characteristics and Antioxidant Effects of Liposomal Glutathione Orally Dissolving Film

A Randomized, Open-Label, Controlled Human Study to Evaluate the Pharmacokinetic Characteristics, Antioxidant Efficacy, and Safety of Liposomal Glutathione Orally Dissolving Film

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011710

Enrollment

Registered

2026-03-11

Start date

2024-11-22

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : This study is conducted as a single-dose, two-treatment, two-sequence, two-period crossover study. Participants receive a single oral dose of liposomal glutathione orally dissolvi

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Male adults aged =40 years who are non-smokers at the time of screening. 2) Individuals who voluntarily agree to participate in this study and provide written informed consent after receiving a full explanation of the study and fully understanding the study procedures and precautions.

Exclusion criteria

Exclusion criteria: 1) Individuals with a history of alcohol abuse or dependence within 3 months prior to screening. 2) Individuals with clinically significant acute or chronic diseases requiring treatment, including cardiovascular or cerebrovascular, endocrine, immune, respiratory, hepatobiliary, renal or urinary, neuropsychiatric, musculoskeletal, inflammatory, hematologic, neoplastic, or gastrointestinal disorders. 3) Individuals who have taken medications or dietary supplements with antioxidant effects within 1 month prior to screening (see prohibited concomitant medications). 4) Individuals with BMI = 30 kg/m². 5) Individuals who have taken neuropsychiatric medications (e.g., antipsychotics, antidepressants, mood stabilizers, hypnotics, or anxiolytics) within 1 month prior to screening. 6) Individuals who donated whole blood within 1 month prior to screening or blood components within 2 weeks prior to screening. 7) Individuals who participated in another clinical study within 3 months prior to screening. 8) Individuals with the following abnormal laboratory findings: -AST or ALT > 3 × upper limit of normal (ULN) -Serum creatinine > 2.0 mg/dL 9) Individuals considered inappropriate for participation in the study by the investigator based on laboratory results or other clinical reasons.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters (GSH iAUC, Cmax, Tmax, t½)	—

Secondary

Measure	Time frame
Plasma reduced glutathione (GSH);Reduced glutathione (GSH)/Oxidized glutathione (GSSG) ratio;Superoxide dismutase (SOD);Catalase (CAT);8-isoprostane;Clinical laboratory tests	—

Countries

Korea, Republic of

Contacts

Public ContactEUN-SOO JUNG

Jeonbuk National University Hospital

esjung@jbctc.org+82-63-259-3049

Outcome results