Gatifloxacin Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Several clinical trials evaluate gatifloxacin across Phase 1, Phase 4, and phase-unspecified studies involving healthy volunteers, patients with endophthalmitis, and individuals with acute coronary syndromes. Sponsored by pharmaceutical companies and academic institutions, including Bausch & Lomb Incorporated, Queen's University, and Bristol-Myers Squibb, these protocols carry documented recruitment statuses of either completed or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00905762	Completed	Healthy	Bausch & Lomb Incorporated	2009-03	Phase 1
NCT00335231	Withdrawn	Endophthalmitis	Queen''s University	2006-06	Not Applicable
NCT00382460	Completed	Actue Coronary Syndromes	Bristol-Myers Squibb	2000-11	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gatifloxacin is a fourth-generation fluoroquinolone antibiotic that directly targets and inhibits the bacterial enzymes DNA gyrase and topoisomerase IV, thereby disrupting essential bacterial DNA replication, repair, and transcription processes. This enzymatic inhibition induces catastrophic double-stranded DNA breakage and bacterial cell death, providing the biological basis for treating ocular bacterial conditions such as endophthalmitis.

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>).