Tetrahydrocurcumin Clinical Trials

Size	Price	Qty
25mg	USD 127
1g	USD 1,270

Clinical Trials

A clinical trial evaluated tetrahydrocurcumin, focusing on the plasma levels and pharmacokinetic characteristics of various curcuminoid formulations. Jointly sponsored by academic and commercial entities, specifically the University of Jordan and Nutritional Fundamentals for Health, this pilot study has completed recruitment. It provides clinical data regarding the systemic bioavailability and comparative absorption profiles of these bioactive 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 Tetrahydrocurcumin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tetrahydrocurcumin acts as a major active metabolite of curcumin that scavenges reactive oxygen species and inhibits key cytochrome P450 enzymes, including CYP2C9 and CYP3A4, thereby blunting oxidative stress cascades and altering xenobiotic metabolism. These cellular and enzymatic actions mitigate oxidative damage and regulate metabolic clearance, which directly underpins its evaluation in clinical settings measuring plasma concentrations and pharmacokinetic profiles of 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>).