Dicloxacillin Sodium Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Multiple completed Phase 1 clinical trials have evaluated dicloxacillin sodium in healthy volunteers to assess its pharmacokinetic profile, drug-drug interactions, and effects on oral drug absorption and enzymatic metabolism. Sponsored by academic and medical institutions, including the University of Southern Denmark and Odense University Hospital, these studies specifically investigated the induction of drug-metabolizing enzymes in human subjects. Overall, clinical research on this compound centers on its pharmacokinetic characterization and metabolic pathways.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05073627	Completed	Healthy Volunteers\|Drug-drug Interaction	University of Southern Denmark	2022-02-07	Phase 1
NCT02983890	Completed	Healthy	Per Damkier\|Odense University Hospital	2016-10-06	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dicloxacillin sodium binds selectively to bacterial penicillin-binding proteins to inhibit transpeptidase-catalyzed peptidoglycan cross-linking, which weakens cell wall integrity and causes osmotic lysis of susceptible bacterial cells. In addition to its primary antibacterial mechanism, dicloxacillin modulates hepatic drug-metabolizing enzymes, providing the physiological rationale for Phase 1 clinical studies evaluating drug-drug interactions and oral drug absorption in healthy volunteers.

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>).