Citrus Extract Clinical Trials

Size	Price	Qty
5mg	USD 90

Clinical Trials

A clinical trial evaluated the safety, metabolic properties, and dose-escalation pharmacokinetics of citrus extract constituents, such as naringenin, to support its development as an anticancer agent. Sponsored by research institutions including the Pennington Biomedical Research Center and the Louisiana Clinical and Translational Science Center, this completed Early Phase I study established foundational pharmacokinetic parameters and safety characteristics required for further therapeutic advancement.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03582553	Completed	Safety Issues\|Pharmacokinetics	Pennington Biomedical Research Center\|Louisiana Clinical and Translational Science Center	2018-05-25	Early Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Citrus extract bioactive flavonoids modulate key pro-survival signaling cascades and cellular oxidative pathways, thereby inhibiting oncogenic cell proliferation and promoting programmed cell death. This antiproliferative and chemopreventive mechanism provides the biological rationale for evaluating the extract's safety profile and single-dose pharmacokinetic characteristics in early-phase clinical trials.

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>).