Ginkgolide B Clinical Trials

Size	Price	Qty
25mg	USD 90
500mg	USD 970

Clinical Trials

A completed Phase 1 clinical trial sponsored by West China Second University Hospital evaluated Ginkgolide B injection in healthy volunteers. The study investigated the safety, tolerability, and pharmacokinetic properties of the drug across single- and multiple-ascending dose regimens. Overall, this foundational evaluation established essential baseline parameters regarding human safety and systemic drug exposure to support potential future therapeutic development.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07457008	COMPLETED	Healthy Volunteers	West China Second University Hospital	2021-07-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ginkgolide B functions as a selective platelet-activating factor receptor (PAFR) antagonist, binding the receptor to inhibit downstream PAF-mediated signaling cascades and reduce cellular responses such as neutrophil degranulation and superoxide production. By dampening these receptor-driven inflammatory pathways, this targeted molecular inhibition provides the mechanistic rationale for evaluating the compound's safety, tolerability, and pharmacokinetic profile in healthy volunteers during Phase 1 clinical studies.

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>).