Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345950
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2024-03-28
Brief Title:
Pharmacokinetics and Safety of a New Micellar Glutathione Formulation
Sponsor:
Factors Group of Nutritional Companies Inc
Organization:
Factors Group of Nutritional Companies Inc
Study Overview
Official Title:
Pharmacokinetics and Safety of a New Micellar Glutathione Formulation in Human Participants
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None