Acesulfame Potassium Clinical Trials

Size	Price	Qty
100mg	USD 150

Clinical Trials

A clinical trial sponsored by George Washington University is currently evaluating the biological disposition and intergenerational transmission of acesulfame potassium to infants through maternal milk. Categorized with a trial phase of Not Applicable, this active, non-recruiting study focuses on the physiological context of breastfeeding. This research provides critical insight into how maternal ingestion of low-calorie sweeteners influences pediatric chemical exposure during early infant lactation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05379270	Active not recruiting	Breastfeeding	George Washington University	2022-02-28	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Acesulfame potassium selectively binds to the T1R2/T1R3 sweet taste receptor complex, triggering gustatory G-protein-coupled signaling pathways without undergoing enzymatic metabolic cleavage. Consequently, the intact compound enters systemic circulation, making its biological disposition directly relevant to clinical studies evaluating the passage of non-nutritive sweeteners into breast milk during lactation.

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>).