Cephalexin Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Several clinical trials evaluate cephalexin across Phase 1 studies focusing on pharmacokinetic, pharmacodynamic, and bioequivalence profiles. These trials assess healthy volunteers as well as pediatric populations with neonatal infections or musculoskeletal conditions such as osteomyelitis, septic arthritis, and pyomyositis, with some investigating specialized pediatric dosing protocols. Sponsored by academic and industrial entities including the University of Colorado Denver, Eli Lilly and Company, and Investigacion Farmacologica y Biofarmaceutica S.A. de C.V., study recruitment statuses range from completed to enrolling by invitation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04916951	Enrolling by invitation	Neonatal Infection	University of Colorado Denver	2021-07-14	Phase 1
NCT03802552	Completed	Osteomyelitis\|Septic Arthritis\|Pyomyositis	University of Colorado Denver	2019-05-01	Phase 1
NCT02490670	Completed	Healthy	Eli Lilly and Company\|Investigacion Farmacologica y Biofarmaceutica S.A. de C.V.	2015-07	Phase 1
NCT02123459	Completed	Healthy Volunteers	Eli Lilly and Company\|Investigacion Farmacologica y Biofarmaceutica S.A. de C.V.	2014-05	Phase 1
NCT02123472	Completed	Healthy Volunteers	Eli Lilly and Company\|Investigacion Farmacologica y Biofarmaceutica S.A. de C.V.	2014-05	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cephalexin binds to and inactivates penicillin-binding proteins involved in bacterial cell wall synthesis, thereby inhibiting peptidoglycan cross-linking and weakening the structural integrity of the cell wall. This disruption leads to osmotic lysis and bacterial cell death, providing therapeutic efficacy against bacterial pathogens in clinical settings such as neonatal infections, osteomyelitis, and septic arthritis.

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>).