Levobupivacaine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate levobupivacaine for labor pain management and arthropathy, encompassing Phase 1 testing alongside protocols designated as Phase Not Applicable. Sponsored by academic and clinical organizations including Assiut University and Chang Gung Memorial Hospital, these studies examine intrathecal drug combinations for labor analgesia as well as the pharmacokinetics and therapeutic efficacy of local administration methods for joint conditions. Currently maintaining an unknown recruitment status, these trial records demonstrate ongoing interest in optimizing local anesthetic delivery and comparative analgesic efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04221568	Unknown status	Labor Pain	Assiut University	2020-03-01	Phase 1
NCT03258697	Unknown status	Arthropathy	Chang Gung Memorial Hospital	2017-10-17	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Levobupivacaine selectively binds to and inhibits voltage-gated sodium channels on neuronal membranes, preventing the sodium influx and membrane depolarization required for nerve impulse generation. By suppressing action potential propagation along sensory and motor nerve fibers, this long-acting anesthetic blocks pain transmission, providing effective localized analgesia relevant to clinical applications such as labor pain and arthropathy.

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>).