Iodixanol Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple Phase 4 clinical trials have evaluated iodixanol, primarily assessing drug safety, patient comfort, chronic kidney failure, and renal insufficiency in patients with diabetes mellitus. Sponsored by academic institutions such as Peking University First Hospital, corporate entities including GE Healthcare, and contract research organizations, these studies feature varied recruitment statuses, including completed, terminated, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01580046	Unknown status	Kidney Failure Chronic	Yong Huo\|Peking University First Hospital	2012-04	Phase 4
NCT01475097	Completed	Drug Safety	GE Healthcare\|i3 Statprobe	2011-10	Phase 4
NCT01376089	Completed	Patient Comfort and Safety	GE Healthcare\|i3 Statprobe	2011-05	Phase 4
NCT00209417	Terminated	Renal Insufficiency\|Diabetes Mellitus	GE Healthcare\|ABX CRO\|Examination Management Services Inc.\|Covance\|Quintiles Inc.\|Averion International Corporation	2005-06	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a nonionic hydrophilic contrast agent, iodixanol absorbs X-ray radiation due to its covalently bound iodine atoms, effectively blocking beam transmission through vascular spaces without disrupting cellular osmotic homeostasis. This iso-osmolar radiopacity minimizes osmotic fluid shifts and endothelial membrane stress, enabling clear vascular opacification during angiography while maintaining patient safety and reducing nephrotoxic risk in individuals with chronic kidney failure or 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>).