Stachydrine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A completed clinical trial sponsored by an academic institution, Chalmers University of Technology, evaluated stachydrine in healthy volunteers to better understand dietary biomarkers and human dose-response relationships. Operating outside a traditional trial phase classification, this study focused on nutritional intake monitoring rather than formal interventional drug development. Consequently, clinical research on stachydrine remains centered on nutritional assessment in healthy populations rather than therapeutic applications for specific disease conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05073523	Completed	Healthy	Chalmers University of Technology	2021-09-27	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Stachydrine suppresses the NF-κB signaling cascade, which downstream blocks the transcription of pro-inflammatory cytokines and reduces cellular oxidative stress. This systemic anti-inflammatory and osmoprotective modulation underlies its excretion dynamics, making stachydrine a valuable target for assessing dietary biomarkers in healthy human trial participants.

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>).