Phenazopyridine HCl Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

A clinical trial evaluated Phenazopyridine HCl to assess the crossover bioequivalence of formulations in healthy human volunteers. Sponsored by Universal Enterprises, the study has an unknown recruitment status, with its trial phase designated as not applicable because it evaluated bioequivalence parameters rather than therapeutic endpoints. Consequently, the clinical landscape for this compound consists of early-stage pharmacological assessment in healthy participants rather than active trials in patient cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00743977	Unknown status	Human Volunteers	Universal Enterprises	2008-08	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phenazopyridine HCl acts as an inhibitor of sodium channel protein type 1 subunit alpha, directly blocking voltage-gated sodium influx across neuronal membranes. This blockade suppresses action potential generation and propagation along sensory nerves, thereby exerting a localized mucosal analgesic effect to relieve pain and irritation associated with urinary tract disorders.

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>).