Ilaprazole Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple clinical trials sponsored by Il-Yang Pharm. Co. Ltd. evaluate the pharmacological profile and therapeutic applications of ilaprazole across Phase I and unclassified study phases. These investigations focus on pharmacokinetic and safety profiles in healthy volunteers under fed and fasting conditions, potential drug interaction potentiation, and Helicobacter pylori eradication regimens. Recruitment statuses across these studies range from completed and recruiting to not yet recruiting and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05617651	Not yet recruiting	Pharmacokinetics	Il-Yang Pharm. Co. Ltd.	2024-11-30	Phase 1
NCT05558150	Completed	Drug Interaction Potentiation	Il-Yang Pharm. Co. Ltd.	2022-11-10	Phase 1
NCT05509543	Recruiting	Pharmacokinetics	Il-Yang Pharm. Co. Ltd.	2022-08-24	Phase 1
NCT03099876	Unknown status	Helicobacter Pylori Infection	Il-Yang Pharm. Co. Ltd.	2017-03-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ilaprazole selectively binds to and inhibits gastric H+/K+-ATPase with an IC50 of 6.0 μM, effectively blocking the terminal hydrogen-potassium exchange required for gastric acid secretion in parietal cells. By suppressing acid production and elevating intra-gastric pH, this proton pump inhibitor promotes gastric mucosal healing and supports clinical efficacy in managing Helicobacter pylori infection, peptic ulcer disease, and gastroesophageal reflux disease.

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>).