Urapidil HCl Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate urapidil hydrochloride, focusing primarily on anesthesia management, systemic hypoxia, post-operative blood pressure responses during neurological embolization, and intensive care gas exchange parameters. Sponsored by academic and clinical medical institutions including the First Affiliated Hospital of Sun Yat-Sen University and University Hospital Caen, these investigations range in recruitment status from unknown to completed. Phase designations across these studies are classified as not applicable or unspecified.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03076099	Unknown status	Anesthesia	Nan Jiang\|First Affiliated Hospital Sun Yat-Sen University	2016-01-01	Not Applicable
NCT05537194	Completed	Hypoxia	University Hospital Caen	1963-01-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Urapidil hydrochloride acts as a dual alpha1-adrenoceptor antagonist and serotonin 5-HT1A receptor agonist, effectively suppressing central sympathetic outflow while blocking peripheral vascular vasoconstrictive signaling. This dual modulation reduces peripheral resistance and systemic vascular tone, providing clinical efficacy for hemodynamic management during surgical anesthesia and conditions involving respiratory hypoxia.

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>).