Diclofenac Diethylamine Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several clinical trials evaluate the pharmacokinetics, safety, and therapeutic applications of diclofenac in postoperative pain management, primary dysmenorrhea, pharmacokinetic interaction evaluations, and safety profiles in healthy participants. Spanning Early Phase 1, Phase 1, and Phase 4, these studies are supported by academic and clinical entities, such as Washington State University and the B.P. Koirala Institute of Health Sciences, as well as industry sponsors Amzell and Daré Bioscience Inc. Recruitment statuses for these trials range from not yet recruiting to active recruitment and active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06053411	Not yet recruiting	Interaction	Washington State University	2024-01-01	Early Phase 1
NCT06146491	Recruiting	Pain Postoperative	B.P. Koirala Institute of Health Sciences	2023-08-10	Phase 4
NCT05968482	Active not recruiting	Healthy	Amzell	2023-07-11	Phase 1
NCT05752526	Active not recruiting	Dysmenorrhea Primary	Daré Bioscience Inc.	2023-05-19	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diclofenac diethylamine binds to and inhibits both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) with relative equipotency, thereby blocking the downstream biosynthesis of pro-inflammatory prostaglandins. This enzymatic inhibition suppresses local inflammatory cascades and nociceptive signaling pathways, establishing its clinical relevance in reducing inflammation and managing conditions such as postoperative pain and primary dysmenorrhea.

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>).