Multiple clinical trials have evaluated rebamipide across diverse study areas, focusing on healthy volunteers, stomach ulcers, therapeutic equivalency, and pharmacogenetics. These studies encompass Phase 1 evaluations of pharmacokinetics and drug interactions alongside Phase Not Applicable designs, sponsored by both pharmaceutical entities such as Korea Otsuka Pharmaceutical and academic healthcare centers like Kangdong Sacred Heart Hospital. Across this research landscape, all trials have successfully completed recruitment.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04150172 | Completed | Healthy Volunteers |
Korea Otsuka Pharmaceutical Co. Ltd. |
2019-04-22 | Phase 1 |
| NCT02106130 | Completed | Healthy |
IlDong Pharmaceutical Co Ltd |
2013-05 | Phase 1 |
| NCT01167101 | Completed | Stomach Ulcer |
Kangdong Sacred Heart Hospital |
2009-05 | Not Applicable |
| NCT00997789 | Completed | Therapeutic Equivalency|Pharmacogenetics |
Chonnam National University Hospital|Institute of Bioequivalence and Bridging Study College of Pharmacy CNU |
2008-03 | Not Applicable |
(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>).