Hydroquinidine Clinical Trials

Size	Price	Qty
100mg	USD 147

Clinical Trials

A late-phase clinical trial evaluated the therapeutic efficacy of oral hydroquinidine in mitigating high cardiac arrhythmic risk in patients with Brugada syndrome. Jointly sponsored by Nantes University Hospital and Sanofi, this academic-industry effort sought to assess the drug's clinical utility before recruitment was ultimately terminated. Consequently, clinical evaluation of hydroquinidine for this condition remains limited.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00927732	Terminated	Brugada Syndrome	Nantes University Hospital\|Sanofi	2009-02	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydroquinidine binds to voltage-gated sodium channels in cardiac myocytes, blocking the rapid inward sodium current during Phase 0 of the cardiac action potential. This inhibition reduces myocardial membrane excitability and slows cardiac impulse conduction, thereby suppressing aberrant signaling to stabilize cardiac rhythm in clinical contexts such as Brugada syndrome.

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>).