Granisetron HCl Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A completed Phase 3 clinical trial sponsored by academic researchers at Cairo University evaluated Granisetron HCl for preventing postoperative nausea and vomiting in patients undergoing strabismus ophthalmic surgeries. The investigation compared 1 mg and 3 mg dosing regimens of Granisetron to optimize antiemetic protocols in surgical care. Overall, this trial reflects targeted research aimed at refining dosing strategies and enhancing postoperative patient outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04918862	Completed	1mg Vs 3 mg of Granisetron	Cairo University\|Mohamed Yousry Mohamed\|Tamer Fayez Safan\|Tamer Mohamed Khair\|Mohamed Ahmed A. M.D.\|Islam Mohamed Sayed	2021-01-08	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Granisetron HCl selectively binds to and antagonizes serotonin 5-HT3 receptors, thereby blocking serotonin-mediated depolarization and suppressing vagus nerve excitation. This inhibition prevents both central and peripheral activation of the emetic reflex, mitigating postoperative and chemotherapy-induced nausea and vomiting in clinical applications.

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>).