Hydroxyzine 2HCl Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

A Phase IV clinical trial sponsored by Rose Research Center LLC and the Foundation for a Smoke Free World INC evaluated hydroxyzine 2HCl combined with varenicline for smoking cessation, stress, sleep disturbance, and nausea. Having completed recruitment, this study underscores clinical interest in using hydroxyzine to alleviate stress and sleep disturbance associated with smoking cessation therapies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04188106	Completed	Smoking Cessation\|Stress\|Sleep Disturbance\|Nausea	Rose Research Center LLC\|Foundation for a Smoke Free World INC	2019-06-17	Phase 4

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

Check the Hydroxyzine 2HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydroxyzine 2HCl acts as a potent histamine H1-receptor antagonist that selectively competes for ligand binding, inhibiting [3H]pyrilamine and [3H]desloratadine binding to the human H1 receptor with IC50 values of 10 nM and 19 nM, respectively. By suppressing H1 receptor-mediated downstream biochemical cascades and central histaminergic signaling, hydroxyzine attenuates neural excitation and sedative-autonomic pathways to help manage stress, sleep disturbance, nausea, and adjunctive challenges in smoking cessation.

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>).