Nicardipine Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Several clinical trials evaluate therapeutic regimens and patient management strategies in perioperative and critical care settings, including studies on coronary artery bypass grafting, acute cholecystitis, hemodynamic instability and nociceptive pain during cardiac or vascular surgery, and cerebral aneurysm intervention. Sponsored by academic and clinical centers such as Sawanpracharak Hospital, Yonsei University, Erasme University Hospital, and Seoul National University Bundang Hospital, these trials list their developmental phase as Not Applicable. Their recruitment statuses range from completed to not yet recruiting and unknown, reflecting ongoing clinical evaluation of cardiovascular and perioperative care protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06238011	Not yet recruiting	CABG	Sawanpracharak hospital	2024-02-28	Not Applicable
NCT05164159	Completed	Acute Cholecystitis	Yonsei University	2022-02-20	Not Applicable
NCT04137991	Completed	Nociceptive Pain\|Goal-directed Therapy\|Hemodynamic Instability\|Nol-Index\|Remifentanil\|Cardiac Surgery\|Vascular Surgery\|General Anesthesia	Erasme University Hospital	2019-10-10	Not Applicable
NCT01460563	Unknown status	Cerebral Aneurysm	Seoul National University Bundang Hospital	2011-10	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nicardipine is a potent L-type calcium channel blocker that selectively binds to voltage-gated calcium channels, inhibiting transmembrane calcium ion influx into vascular smooth muscle cells. This inhibition prevents intracellular calcium-dependent excitation-contraction coupling, resulting in vascular smooth muscle relaxation, systemic arterial vasodilation, and reduced vascular resistance to maintain hemodynamic stability during surgical procedures and acute vascular conditions.

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>).