Narirutin Clinical Trials

Size	Price	Qty
1mg	USD 147

Clinical Trials

Multiple clinical trials involving narirutin, each designated as Phase Not Applicable, assess citrus flavanone bioavailability and physiological responses in healthy volunteers and populations with hypertension or blood pressure management needs. Sponsored by academic and institutional entities such as the Technological Centre of Nutrition and Health in Spain and the University of Hohenheim, recruitment progress across these studies ranges from completed to unknown. Overall, this clinical landscape highlights preliminary human bioavailability and physiological outcomes associated with narirutin intake.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04234100	Completed	Blood Pressure\|Hypertension	Technological Centre of Nutrition and Health Spain	2020-02-24	Not Applicable
NCT02380144	Unknown status	Healthy	University of Hohenheim	2014-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a citrus-derived flavanone, narirutin neutralizes reactive oxygen species and suppresses pro-inflammatory signaling cascades, thereby attenuating cellular oxidative stress and inflammatory mediator release. This reduction in vascular oxidative injury and cellular stress promotes endothelial health and smooth muscle relaxation, providing a rational biological basis for its clinical evaluation in blood pressure regulation and hypertension.

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>).