Diphenhydramine HCl Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple clinical trials evaluate diphenhydramine across Phase 1 through Phase 4, investigating conditions including post-operative nausea and vomiting, pain, central nervous system effects and pharmacokinetics, and cannabis hyperemesis syndrome. Sponsored by entities such as the Milton S. Hershey Medical Center, HALEON, Dent Neuroscience Research Center, and Mercy Health Ohio in collaboration with the Lake Erie College of Osteopathic Medicine, these studies encompass various recruitment statuses, including recruiting, completed, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05759481	Recruiting	Post-operative Nausea and Vomiting	Milton S. Hershey Medical Center	2024-02-01	Phase 2
NCT05674721	Completed	Pain	HALEON	2023-01-05	Phase 1
NCT05219604	Terminated	Central Nervous System Effects of Diphenhydramine\|Pharmacokinetics of Diphenhydramine	Dent Neuroscience Research Center	2022-03-15	Phase 4
NCT05244460	Recruiting	Cannabis Hyperemesis Syndrome	Mercy Health Ohio\|Lake Erie College of Osteopathic Medicine	2021-12-02	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diphenhydramine HCl functions as a competitive histamine H1 receptor antagonist, binding to target H1 receptors to block downstream histamine-mediated signal transduction pathways. This receptor blockade inhibits effector cell activation and vascular permeability, thereby mitigating allergic reactions, pain, and central emetic signaling in clinical settings such as post-operative nausea and vomiting.

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>).