Lercanidipine Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 470

Clinical Trials

A clinical trial is currently recruiting participants to evaluate the pharmacokinetics of lercanidipine in patients with morbid obesity undergoing bariatric surgery. Lacking a designated phase classification, the study is sponsored by a consortium of academic and clinical institutions, including the Norwegian University of Science and Technology and several regional hospitals. These efforts aim to clarify drug disposition alterations in this patient population.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03497156	Recruiting	Obesity Morbid	Norwegian University of Science and Technology\|St. Olavs Hospital\|Volvat Medisinsk Senter Stokkan\|Namsos Hospital\|Alesund Hospital	2016-11-02	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lercanidipine selectively binds to L-type voltage-dependent calcium channels in vascular smooth muscle membranes, blocking calcium ion influx and disrupting calcium-mediated downstream signaling pathways. The resulting vascular relaxation and reduction in systemic vascular resistance lower blood pressure, establishing the therapeutic mechanism under pharmacological and pharmacokinetic investigation in populations with morbid obesity.

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>).