Mosapride Citrate Clinical Trials

Size	Price	Qty
10mg	USD 79

Clinical Trials

A clinical trial evaluating Mosapride Citrate, sponsored by commercial pharmaceutical sponsor IlDong Pharmaceutical Co Ltd, was conducted in healthy subjects. This completed Phase I investigation was designed as a randomized, open-label crossover study to assess pharmacokinetic drug interactions following multiple dose administrations. Current registry data indicates that clinical development efforts have focused on evaluating initial safety and drug interaction profiles in healthy volunteers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02106130	Completed	Healthy	IlDong Pharmaceutical Co Ltd	2013-05	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mosapride Citrate selectively binds to and stimulates 5-HT4 receptors on enteric neurons, inducing adenylate cyclase activation and promoting postganglionic acetylcholine release in the gastrointestinal tract. This enhancement of cholinergic transmission increases gastrointestinal smooth muscle contractility to accelerate gastric emptying, establishing the biological rationale for evaluating its pharmacokinetic profile and prokinetic effects in healthy clinical trial subjects.

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>).