Ondansetron Clinical Trials

Size	Price	Qty
10mg	USD 147
200mg	USD 690

Clinical Trials

A Phase 2 clinical trial sponsored by the Milton S. Hershey Medical Center, an academic medical institution, is currently actively recruiting to evaluate the therapeutic application of ondansetron. The investigation focuses on clinical interventions aimed at preventing post-operative nausea and vomiting by mitigating emetic responses following surgical procedures. Overall, this research reflects an academic effort targeted at optimizing patient outcomes in post-operative emesis management.

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

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ondansetron selectively binds to and antagonizes serotonin 5-HT3 receptors on peripheral vagus nerve terminals and centrally in the chemoreceptor trigger zone, thereby blocking serotonin-mediated signaling pathways and suppressing the activation of the medullary vomiting center. By inhibiting these neural emetic reflex arcs, this targeted receptor blockade prevents signaling that triggers nausea and emesis, rendering it clinically relevant for preventing post-operative nausea and vomiting in surgical patients.

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>).