Maltose monohydrate Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple clinical trials evaluate maltose monohydrate across metabolic and oncological conditions, specifically targeting diabetes mellitus, type 2 diabetes, and advanced solid tumors. Sponsored by academic institutions such as Bastyr University and pharmaceutical companies including Anaeropharma Science Inc. and Lee's Pharmaceutical Limited, these studies encompass Phase 1/2 safety evaluations, Phase 2 efficacy trials, and non-applicable phase device or behavioral interventions. The recruitment statuses for these initiatives encompass completed studies, suspended investigations, and trials with an unknown status.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Maltose monohydrate acts as a disaccharide substrate that is hydrolyzed by intestinal alpha-glucosidase enzymes into individual glucose units to fuel cellular energetic pathways. This enzymatic degradation regulates downstream glucose absorption and systemic nutrient availability, providing direct clinical relevance for managing metabolic dynamics in diabetes mellitus and supporting metabolic delivery systems in oncology clinical trials.

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>).