Propantheline bromide Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials have evaluated the therapeutic potential of propantheline bromide for urological conditions, including a Phase 1 study sponsored by Hospital Universitário Professor Edgard Santos targeting overactive bladder associated with human T-lymphotropic virus type 1 (HTLV-1) and a Phase 4 study by Chongqing Medical University for urinary calculus. These trials currently have an unknown recruitment status, reflecting a limited clinical trial landscape focused primarily on urinary system disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01640002	UNKNOWN	Overactive Bladder Associated With HTLV-1	Hospital Universitário Professor Edgard Santos	2012-05	PHASE1
NCT01010048	UNKNOWN	Urinary Calculus	Chongqing Medical University	2009-10	PHASE4

(data from https://clinicaltrials.gov, updated on 2012-07-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Propantheline bromide competitively binds to muscarinic acetylcholine receptors, thereby inhibiting parasympathetic neurotransmission and blocking downstream signal transduction that triggers smooth muscle contraction. This targeted receptor inhibition induces visceral smooth muscle relaxation and decreases glandular secretions, providing a rationale for mitigating smooth muscle spasms in clinical conditions such as overactive bladder and urinary calculus.

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>).