Bethanechol chloride Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

A completed Phase IV clinical trial sponsored by the Department of Medical Services under the Ministry of Public Health of Thailand evaluated the therapeutic efficacy of Bethanechol chloride alongside early bladder training for post-surgical bladder dysfunction in cervical cancer patients undergoing radical hysterectomy. This study demonstrates the agent's clinical utility in post-operative recovery, reflecting targeted late-stage research in post-operative bladder management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02910596	COMPLETED	Bladder Dysfunction	Department of Medical Services Ministry of Public Health of Thailand	2016-10-01	PHASE4

(data from https://clinicaltrials.gov, updated on 2020-10-23)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bethanechol chloride acts as a selective muscarinic receptor agonist that resists cholinesterase hydrolysis, directly binding muscarinic acetylcholine receptors to stimulate parasympathetic neurotransmission and induce detrusor smooth muscle contraction. By increasing urinary bladder tone and facilitating micturition, this sustained parasympathomimetic activity provides the physiological basis for restoring lower urinary tract function in patients with bladder dysfunction.

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>).