Propafenone HCl Clinical Trials

Size	Price	Qty
10mg	USD 280

Clinical Trials

Multiple clinical trials evaluating Propafenone HCl have been completed, encompassing Phase 1 and Phase 4 studies. These trials evaluated bioavailability and bioequivalence in healthy adult volunteers, alongside therapeutic efficacy and safety in patients with supraventricular arrhythmia and septic shock. Sponsorship was held by commercial and academic entities, including Pharmtechnology LLC in collaboration with Altasciences Company Inc., and Charles University.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03915340	Completed	Bioequivalence	Pharmtechnology LLC\|Altasciences Company Inc.	2019-03-23	Phase 1
NCT03029169	Completed	Supraventricular Arrhythmia\|Septic Shock	Charles University Czech Republic	2017-10-23	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Propafenone HCl functions by binding to voltage-gated sodium channels in myocardial cells, thereby blocking the fast inward flux of sodium ions during membrane depolarization. This inhibition reduces cardiac cell excitability and slows electrical conduction velocity, suppressing ectopic pacemaker activity to restore normal cardiac rhythm in clinical conditions such as supraventricular arrhythmia.

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>).