Maltose Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate maltose across diverse medical applications, focusing primarily on diabetes mellitus and advanced neoplasms. Sponsored by academic and commercial entities such as Lee's Pharmaceutical Limited and Bastyr University, these investigations span Phase 1/2, Phase 2, and non-applicable phase designations for diagnostic or device evaluations. Across completed, suspended, and unknown recruitment statuses, protocols have explored maltose in combination therapies for solid tumors as well as glucose sensing in diabetic populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03008239	Unknown status	Diabetes Mellitus	Lee''s Pharmaceutical Limited	2017-11-14	Not Applicable
NCT03061851	Unknown status	Diabetes Mellitus Type 2	Qingdao Zhixin Health Technology Co. Ltd.\|H & J CRO International Inc.	2017-01-25	Not Applicable
NCT01839344	Completed	Diabetes Mellitus Type 2	Bastyr University	2013-05	Phase 2
NCT01562626	Suspended	Tumors\|Neoplasms\|Cancer	Anaeropharma Science Inc.	2012-09	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Maltose acts as a disaccharide substrate that specifically binds to intestinal alpha-glucosidase, undergoing catalytic hydrolysis into glucose monomers to drive downstream glycolysis and cellular ATP generation. Understanding and modulating this enzymatic carbohydrate breakdown is clinically relevant in regulating postprandial glucose dynamics in type 2 diabetes mellitus and evaluating nutrient transport in neoplastic conditions.

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>).