Levobupivacaine HCl Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several clinical trials sponsored by academic and clinical medical centers, specifically Assiut University and Chang Gung Memorial Hospital, evaluate Levobupivacaine HCl for applications in labor pain and arthropathy. These studies, which encompass Phase 1 and non-applicable phase classifications with unknown recruitment statuses, investigate intrathecal administration for labor analgesia as well as local injection techniques and pharmacokinetics for joint disorders.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Levobupivacaine HCl reversibly binds to neuronal voltage-gated sodium channels, blocking intracellular sodium influx and preventing the depolarization required for action potential propagation along sensory nerve fibers. This disruption of nerve impulse conduction suppresses peripheral nociceptive signaling, providing localized analgesia pertinent to the management of conditions 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>).