Glucosamine sulfate Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A completed Phase 1 clinical trial sponsored by the Fred Hutchinson Cancer Center evaluated the physiological effects of glucosamine and chondroitin supplementation. The study assessed human biological responses to this dietary supplement combination in healthy and overweight cohorts. Consequently, clinical research on glucosamine sulfate is currently characterized by limited, early-stage testing in these populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03827161	Completed	Healthy Subject\|Overweight	Fred Hutchinson Cancer Center	2017-08-01	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an essential amino sugar precursor, glucosamine sulfate is incorporated into glycosaminoglycan and proteoglycan biosyntheses within chondrocytes, thereby promoting extracellular matrix structural integrity and dampening inflammatory signaling pathways. This enhancement of cartilage matrix restoration attenuates enzymatic joint tissue degradation, supporting its clinical evaluation for maintaining joint health in osteoarthritis as well as in physiological studies involving healthy and overweight individuals.

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>).