Voglibose Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

A clinical trial has evaluated the application of voglibose in patients with type 2 diabetes mellitus. Sponsored by pharmaceutical industry collaborators including AstraZeneca and Bristol-Myers Squibb, this completed Phase I study assessed the drug's safety, tolerability, pharmacokinetics, and drug-drug interactions. Overall, these data reflect a focused early-stage investigation into the pharmacokinetic profile and metabolic safety of voglibose for managing type 2 diabetes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01055652	Completed	Type 2 Diabetes Mellitus	AstraZeneca\|Bristol-Myers Squibb	2010-01	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Voglibose functions as a potent inhibitor of intestinal alpha-glucosidases, binding active sites on these digestive enzymes to suppress the enzymatic hydrolysis of complex carbohydrates into absorbable monosaccharides within the small intestine. This reduction in carbohydrate cleavage delays intestinal glucose absorption, thereby blunting postprandial blood glucose spikes and providing therapeutic benefit in managing 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>).