Clinical Trials

A completed clinical trial sponsored by an academic institution, the University of Glasgow, evaluated the physiological and pharmacokinetic profiles of eriodictyol in healthy subjects. Operating under a non-applicable trial phase, the investigation explored how endurance training status in athletes affects the oral bioavailability of flavanones. Consequently, clinical research on eriodictyol remains limited to baseline metabolic studies in healthy cohorts rather than evaluations for specific therapeutic conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02627547 Completed
Healthy
University of Glasgow
2013-09 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a natural flavonoid derived from yerba santa, eriodictyol directly scavenges reactive oxygen species and modulates pro-inflammatory signaling cascades, thereby dampening oxidative stress and suppressing cellular inflammatory responses. This fundamental antioxidant and anti-inflammatory activity underpins its physiological bioactivity and systemic absorption parameters evaluated in healthy individuals.

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>).

Note: Technical data last updated: Sep 1, 2026.