Naftopidil Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A completed, industry-sponsored Phase 1 clinical trial by Dong-A ST Co. Ltd. investigated the clinical profile of naftopidil in healthy male volunteers. The study evaluated the safety, tolerability, and pharmacokinetic parameters of the compound following oral administration to establish foundational physiological data regarding its disposition.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00967772	Completed	Healthy	Dong-A ST Co. Ltd.	2009-09	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Naftopidil acts as a selective α1-adrenergic receptor antagonist that binds directly to α1-adrenoceptor subtypes, thereby blocking norepinephrine-mediated downstream contractile signaling pathways. This receptor blockade promotes smooth muscle relaxation in vascular and genitourinary tissues, which underscores its clinical evaluation for safety, tolerability, and pharmacokinetic properties in healthy trial participants.

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>).