Rebaudioside A Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A completed Phase 1 clinical trial sponsored by Universitaire Ziekenhuizen KU Leuven investigated the therapeutic potential of Rebaudioside A in patients diagnosed with Type 2 Diabetes Mellitus. Specifically, the study evaluated how acute oral administration of the compound affects postprandial glucose excursion following an oral glucose tolerance challenge. Overall, clinical research on Rebaudioside A remains in early stages, focusing on its acute metabolic effects and glycemic control capabilities in subjects with metabolic disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03510624	Completed	Type 2 Diabetes Mellitus	Universitaire Ziekenhuizen KU Leuven	2018-11-09	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Rebaudioside A product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rebaudioside A directly inhibits α-glucosidase activity and blocks ATP-sensitive potassium channels, thereby delaying enzymatic hydrolysis of complex carbohydrates and altering cell membrane polarization. This suppression of intestinal glucose processing and modulation of cellular ionic flux reduces acute postprandial glucose absorption, providing a mechanistic foundation for regulating blood sugar excursions in patients with Type 2 Diabetes Mellitus.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).