Alfuzosin HCl Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple clinical trials evaluate the therapeutic profile and bioequivalence of alfuzosin hydrochloride across Phase 1, Phase 3, and Phase 4 investigations. Supported by major sponsors including Sanofi, Pharma Nueva, and Centre Hospitalier Universitaire de Nîmes, these studies encompass healthy volunteers and patients with benign prostatic hyperplasia, acute urinary retention, or renal colic. Recruitment statuses across this trial portfolio range from completed late-phase studies to withdrawn or pending early-phase trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06316336	Not yet recruiting	Healthy Vollunteer	Pharma Nueva	2024-06-10	Phase 1
NCT01685658	Withdrawn	Renal Colic\|Acute Renal Colic	Centre Hospitalier Universitaire de Nīmes	2016-09	Phase 4
NCT00637715	Completed	Benign Prostatic Hyperplasia	Sanofi	2003-10	Phase 4
NCT00290030	Completed	Prostatic Hyperplasia\|Acute Urinary Retention	Sanofi	2001-05	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alfuzosin hydrochloride selectively binds to and antagonizes alpha1-adrenergic receptors, thereby preventing endogenous catecholamine binding and suppressing receptor-mediated intracellular signaling cascades. This blockade relaxes smooth muscle cells within the prostate stroma and bladder neck, which decreases resistance to urine outflow and relieves lower urinary tract symptoms associated with benign prostatic hyperplasia and acute urinary retention.

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>).