Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT05370261
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2022-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacological Profile of Different Berberine Formulations, and Effects on Blood Sugar Levels
Sponsor:
Factors Group of Nutritional Companies Inc.
Organization:
Study Overview
Official Title:
Comparing the Pharmacological Profile of Different Berberine Formulations, and Their Effects on Blood Sugar Levels
Status:
COMPLETED
Status Verified Date:
2023-02
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:
The primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation. Several pharmacokinetic parameters are compared.
As secondary objective, the immediate or short-term effects of Berberine supplementation on blood sugar levels in healthy volunteers are evaluated via a glucose tolerance test (OGTT) using a portable glucometer.
As secondary objective, the immediate or short-term effects of Berberine supplementation on blood sugar levels in healthy volunteers are evaluated via a glucose tolerance test (OGTT) using a portable glucometer.
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?: