Gliclazide Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Gliclazide has been evaluated in several completed clinical trials targeting healthy volunteers and patients with type 2 diabetes mellitus, consisting primarily of Phase 1 and non-phase-specific studies. Sponsored by academic institutions—including the University of Dundee, University of Sarajevo, and the Chinese University of Hong Kong—alongside industry sponsors such as Merck KGaA, these investigations assessed clinical bioequivalence, food effects on combination formulations, drug interactions with omeprazole, and sulphonylurea synergy with incretins.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04198948	Completed	Diabetes Mellitus Type 2	University of Sarajevo\|General Hospital Prim. Dr. Abdulah Nakas\|University of Dundee\|Wellcome Trust	2019-03-04	Phase 1
NCT03705195	Completed	Type 2 Diabetes Mellitus	University of Dundee\|NHS Tayside	2018-08-03	Not Applicable
NCT03467971	Completed	Healthy	Merck KGaA Darmstadt Germany	2018-03-06	Phase 1
NCT02643329	Completed	Healthy	Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited\|Chinese University of Hong Kong	2016-01	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gliclazide binds to sulfonylurea receptors on pancreatic beta cells to inhibit ATP-sensitive potassium currents, which reduces potassium efflux, induces membrane depolarization, and promotes calcium influx to trigger exocytosis of insulin-containing vesicles. This stimulated secretion of endogenous insulin lowers blood glucose levels, offering direct therapeutic relevance for glycemic control in patients with type 2 diabetes mellitus.

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>).