L-Carnitine hydrochloride Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

A clinical trial sponsored by Haisco Pharmaceutical Group Co. Ltd. is currently actively recruiting participants to evaluate L-carnitine hydrochloride for the treatment of diabetic peripheral neuropathic pain. Designated with a trial phase of Not Applicable, the study assesses the combined efficacy and safety profile of L-carnitine hydrochloride tablets administered alongside HSK16149 capsules and lipoic acid. Overall, current clinical research reflects a targeted evaluation of L-carnitine hydrochloride within combination regimens for neuropathic pain management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06122012	Recruiting	Diabetic Peripheral Neuropathic Pain	Haisco Pharmaceutical Group Co. Ltd.	2023-05-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-Carnitine hydrochloride functions by binding and transporting long-chain fatty acyl-CoAs into the mitochondria to promote β-oxidation while concurrently inhibiting leukotriene synthesis and improving oxygen saturation. This restoration of mitochondrial fatty acid metabolism and reduction of inflammatory mediators enhances cellular bioenergetics and neuronal viability, offering therapeutic relevance in diabetic peripheral neuropathic pain.

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>).