Diclofenac Epolamine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

An academic-led, completed Early Phase 1 clinical trial sponsored by Northwestern University evaluated diclofenac epolamine in the context of breast cancer. This pilot investigation aimed to assess the uniformity of transdermal drug delivery to human breast tissue using the compound as a model pharmaceutical agent. Consequently, recorded clinical research for this compound remains focused on early-stage exploratory evaluation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01380353	Completed	Breast Cancer	Northwestern University	2011-06	Early Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diclofenac epolamine binds to and inhibits cyclooxygenase enzymes (COX-1 and COX-2), thereby blocking the downstream conversion of arachidonic acid into pro-inflammatory prostaglandins. This inhibition reduces localized inflammatory mediator production and nociceptive signaling, providing the mechanistic basis for evaluating its topical penetration and anti-inflammatory properties in conditions such as breast cancer.

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>).