Enrofloxacin Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 470

Clinical Trials

Several clinical trials have evaluated Enrofloxacin in healthy human subjects to assess its pharmacokinetic profile across dermal, inhaled, and oral exposure routes. Sponsored by German research and occupational health institutions, including the Fraunhofer Institute for Toxicology and Experimental Medicine and the Federal Institute for Occupational Safety and Health, these initiatives have completed recruitment with trial phases listed as not applicable. Ultimately, these studies establish essential baseline exposure and safety parameters in healthy, non-patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03575312	COMPLETED	Healthy	Fraunhofer-Institute of Toxicology and Experimental Medicine	2018-04-27
NCT03575312	Completed	Healthy	Fraunhofer-Institute of Toxicology and Experimental Medicine\|Federal Institute for Occupational Safety and Health (BAuA)/Germany)	2018-04-27	Not Applicable

(data from https://clinicaltrials.gov, updated on 2018-12-12)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enrofloxacin binds to and inhibits bacterial DNA gyrase and topoisomerase IV, thereby disrupting essential DNA supercoiling, replication, and RNA transcription processes. This enzyme inhibition causes double-stranded DNA cleavage and rapid bactericidal cell death, supporting its clinical evaluation for pharmacokinetic characterization in healthy human subjects.

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>).