Melamine Clinical Trials

Size	Price	Qty
1mg	USD 97

Clinical Trials

Multiple clinical trials sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital and associated academic investigators have completed recruitment to evaluate melamine exposure in healthy individuals and tableware manufacturing personnel. Designated with a phase of Not Applicable due to their observational and exposure-mitigation study designs, these clinical trials focus on environmental and occupational chemical exposure. Collectively, these research efforts aim to characterize human exposure pathways, biomarker excretion, and strategies to minimize renal impacts associated with ambient chemical exposure.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02719262	Completed	Environmental Exposure	Kaohsiung Medical University Chung-Ho Memorial Hospital	2016-03-26	Not Applicable
NCT02251405	Completed	Healthy Subjects	Ming-Tsang Wu\|Kaohsiung Medical University Chung-Ho Memorial Hospital	2014-10	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a nitrogen-rich heterocyclic compound, melamine interacts with endogenous urinary metabolites such as uric acid to form insoluble crystalline complexes within the renal collecting ducts, causing mechanical obstruction and membrane disruption in tubular epithelial cells. This crystal-induced nephrotoxicity impairs normal renal excretion pathways, making the biochemical assessment of melamine accumulation directly relevant to clinical studies investigating environmental exposure risks and renal health in manufacturing workers and healthy subjects.

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>).