Hexahydrocurcumin Clinical Trials

Size	Price	Qty
1mg	USD 470
5mg	USD 1,409

Clinical Trials

A clinical trial has evaluated hexahydrocurcumin to assess the plasma levels and pharmacokinetic profiles of various curcuminoid formulations. This completed pilot study, which was not assigned a formal trial phase, was sponsored by academic and nutritional organizations, specifically the University of Jordan and Nutritional Fundamentals for Health. The research focused on measuring circulating levels of hexahydrocurcumin to better understand the systemic availability of curcuminoid compounds.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05542394	Completed	Plasma Levels of Different Curcuminoids Preparations	University of Jordan\|Nutritional Fundamentals for Health	2022-09-20	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hexahydrocurcumin selectively binds to and inhibits cyclooxygenase-2 (COX-2), preventing the conversion of arachidonic acid into pro-inflammatory prostaglandins and suppressing downstream cellular oxidative stress and proliferation. Evaluating plasma levels of this major metabolite is clinically essential for determining the systemic pharmacokinetic profile and therapeutic anti-inflammatory efficacy of various curcuminoid preparations.

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>).