Propafenone Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 290

Clinical Trials

Multiple completed clinical trials have evaluated propafenone across distinct phases and therapeutic indications. In an industry-sponsored Phase 1 study by Pharmtechnology LLC and Altasciences Company Inc., researchers assessed the comparative bioavailability and bioequivalence of propafenone film-coated tablets in healthy volunteers. Additionally, an academic Phase 4 trial conducted by Charles University investigated the efficacy and safety of propafenone as a class 1c antiarrhythmic for managing supraventricular arrhythmia in patients experiencing septic shock.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Propafenone acts as an orally active sodium channel blocker and beta-adrenergic receptor antagonist, binding to cardiac voltage-gated sodium channels and beta-adrenoceptors to inhibit inward sodium currents and attenuate adrenergic signaling. This dual action suppresses cellular excitability and slows action potential conduction through myocardial tissue, rendering it clinically effective in controlling cardiac 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>).