Norfloxacin Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

A clinical trial sponsored by an institutional clinical center, the Institute of Liver and Biliary Sciences India, is investigating the therapeutic potential of norfloxacin in human subjects. The study evaluates the comparative efficacy of norfloxacin against rifaximin for secondary prophylaxis of spontaneous bacterial peritonitis. Classified as Phase Not Applicable, the trial is currently not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06199843	Not yet recruiting	Spontaneous Bacterial Peritonitis	Institute of Liver and Biliary Sciences India	2024-01-05	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Norfloxacin binds to and inhibits bacterial DNA gyrase and topoisomerase IV, thereby disrupting essential DNA topological uncoiling and replication machinery. By blocking bacterial chromosome duplication and arresting cell division, this mechanism exerts potent antimicrobial activity relevant to preventing and treating conditions like spontaneous bacterial peritonitis.

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>).