Sodium cholate Clinical Trials

Size	Price	Qty
25mg	USD 107

Clinical Trials

Multiple clinical trials evaluating sodium cholate across distinct medical conditions have completed recruitment. A Phase 1/Phase 2 study sponsored by academic and research institutions investigated nicotine dependency in patients with tobacco use disorder and schizophrenia. Additionally, an unphased study conducted by an academic health science center evaluated sodium channel expression related to dental pulp disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00618280	Completed	Tobacco Use Disorder\|Schizophrenia	Heinrich-Heine University Duesseldorf\|German Research Foundation	2008-01	Phase 1\|Phase 2
NCT00575263	Completed	Dental Pulp Disease	The University of Texas Health Science Center at San Antonio	2006-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium cholate is an amphipathic bile salt that physically interacts with lipid bilayers, disrupting cell membrane integrity and altering membrane-associated ion channel dynamics. This detergent action alters cellular barrier permeability and transmembrane signaling, providing a mechanistic foundation for its investigation in dental pulp disease as well as neurobehavioral formulations for tobacco use disorder and schizophrenia.

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>).