Flurbiprofen Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Several clinical trials evaluate flurbiprofen across applications such as postoperative analgesia in thoracic or cesarean procedures, postoperative sleep quality following breast tumor surgery, and drug interaction evaluations in healthy volunteers. Spanning Phase 1, Phase 4, and non-assigned designations, these studies encompass completed, actively recruiting, and not-yet-recruiting protocols. Research is supported by sponsors including Qilu Hospital of Shandong University, First People's Hospital of Chenzhou, NorthSea Therapeutics B.V., and Zhongnan Hospital.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05901389	Not yet recruiting	Lidocaine\|Analgesia\|Pain Postoperative\|Thoracic Surgery	Qilu Hospital of Shandong University	2023-06	Not Applicable
NCT05622656	Recruiting	Pain Postoperative	First People''s Hospital of Chenzhou	2022-12-01	Phase 4
NCT05368831	Completed	Healthy Volunteers	NorthSea Therapeutics B.V.	2022-07-19	Phase 1
NCT04805775	Completed	Desflurane\|Propofol\|Postoperative Sleep\|PSQI\|Breast Tumor	Zhongnan Hospital	2021-10-21	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Flurbiprofen non-selectively inhibits cyclooxygenase enzymes, thereby blocking the conversion of arachidonic acid into pro-inflammatory prostaglandin precursors. This enzymatic inhibition suppresses localized inflammatory signaling and peripheral nociceptive sensitization, providing the physiological basis for its clinical utility in alleviating postoperative pain and managing surgical inflammation.

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>).