Cetirizine DiHCl Clinical Trials

Size	Price	Qty
50mg	USD 147
200mg	USD 247

Clinical Trials

Multiple clinical trials sponsored by Organon and Co have evaluated Cetirizine DiHCl in Phase 4 studies focusing on pediatric allergic conditions. These trials have completed recruitment and evaluated patient medication preferences comparing chewable cetirizine tablets against desloratadine Reditab formulations. These completed investigations reflect late-stage clinical evaluations aimed at optimizing treatment options for allergic disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00779116	Completed	Allergies	Organon and Co	2005-09	Phase 4
NCT00780403	Completed	Allergies	Organon and Co	2005-08	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cetirizine DiHCl acts as a selective histamine H1 receptor inverse agonist, binding to H1 receptors to stabilize the inactive conformation and inhibit histamine-mediated downstream signal transduction. By suppressing pro-inflammatory cellular pathways and vascular permeability triggered by histamine, this targeted mechanism effectively mitigates clinical manifestations associated with allergies.

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>).