Aceclofenac Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A completed Phase 1 clinical trial sponsored by the pharmaceutical company Il-Yang Pharm. Co. Ltd. investigated aceclofenac to evaluate safety outcomes and pharmacokinetic parameters following multi-dose co-administration with concurrent medications. This early-phase pharmacology study assessed drug interaction potentiation to establish safety profiles and determine potential drug-drug interactions within multi-drug treatment regimens.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05558150	Completed	Drug Interaction Potentiation	Il-Yang Pharm. Co. Ltd.	2022-11-10	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aceclofenac selectively inhibits cyclooxygenase enzymes, thereby blocking the conversion of arachidonic acid into pro-inflammatory prostaglandins. This enzymatic inhibition suppresses mediator-driven inflammatory cascades and pain pathways, which is critical when evaluating its pharmacokinetic profile and drug interaction potentiation during therapeutic co-administration.

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>).