Ibuprofen Lysine Clinical Trials

Size	Price	Qty
20mg	USD 120

Clinical Trials

Multiple clinical trials have evaluated the therapeutic and pharmacokinetic profiles of ibuprofen lysine across Phase I and Phase II research. Early-phase trials sponsored by commercial entities, such as Reckitt Benckiser Healthcare and Oxford Pharmascience, have primarily assessed drug bioavailability, absorption, and formulation disintegration, although select studies were terminated. Additionally, a clinical trial sponsored by Mount Sinai Hospital, Canada, is actively recruiting premature infants to evaluate duct-related outcomes in patent ductus arteriosus.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05340582	RECRUITING	Patent Ductus Arteriosus After Premature Birth	Mount Sinai Hospital, Canada	2022-12-12	PHASE2
NCT03180879	COMPLETED	Healthy	Reckitt Benckiser Healthcare (UK) Limited	2017-04-10	PHASE1
NCT02974361	COMPLETED	Pharmacokinetics	Oxford Pharmascience Ltd	2016-12	PHASE1
NCT03497715	TERMINATED	Healthy Subjects	Reckitt Benckiser Healthcare (UK) Limited	2015-04-14	PHASE1
NCT02452450	COMPLETED	Healthy Volunteer Study	Reckitt Benckiser Healthcare (UK) Limited	2014-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ibuprofen Lysine acts as a non-selective cyclooxygenase inhibitor, binding to the enzyme's active site to block the enzymatic conversion of arachidonic acid into pro-inflammatory prostaglandins and thromboxanes. By suppressing local prostaglandin synthesis, the compound attenuates systemic inflammatory signaling and induces vascular smooth muscle constriction, providing therapeutic relevance in pain management and the medical closure of patent ductus arteriosus in premature infants.

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>).