Doxycycline monohydrate Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

A completed Phase II clinical trial sponsored by NanoSHIFT LLC evaluated the safety and therapeutic efficacy of a topical doxycycline monohydrate hydrogel in adult patients with diabetic foot ulcers. This study underscores targeted industry efforts to utilize doxycycline monohydrate within chronic wound healing and dermatological disease management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00764361	Completed	Diabetic Foot Ulcer	NanoSHIFT LLC	2009-01	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Doxycycline monohydrate reversibly binds to the 30S ribosomal subunit in susceptible microorganisms, thereby inhibiting aminoacyl-tRNA attachment to the mRNA-ribosome complex and blocking downstream bacterial protein synthesis. By suppressing microbial growth and downregulating tissue-degrading matrix metalloproteinases, this mechanism provides therapeutic utility in promoting wound recovery in clinical conditions such as diabetic foot ulcers.

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>).