Several clinical trials spanning Phase 1, Phase 3, and Phase 4 development have evaluated mosapride across indications including postoperative ileus, endoscopic preparation regarding foreign body retention, bioequivalence, and pharmacokinetic profiles in healthy volunteers. Sponsored by academic institutions and pharmaceutical companies, such as Hospital Italiano de Buenos Aires, IlDong Pharmaceutical, Inje University, and Daewoong Pharmaceutical, these studies include both completed initiatives and those with unknown recruitment statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02056405 | Unknown status | Postoperative Ileus |
Hospital Italiano de Buenos Aires |
2015-12 | Phase 4 |
| NCT02106130 | Completed | Healthy |
IlDong Pharmaceutical Co Ltd |
2013-05 | Phase 1 |
| NCT01284764 | Completed | Foreign Body Left During Endoscopic Examination |
Inje University |
2011-01 | Phase 3 |
| NCT01094847 | Completed | Bioequivalence |
Daewoong Pharmaceutical Co. LTD. |
2010-04 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
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>).