Clinical Trials

Multiple clinical trials evaluate rabeprazole for gastrointestinal diseases, Helicobacter pylori infection, and pharmacokinetic assessments in healthy volunteers. Supported by academic institutions and industry sponsors, these Phase 1 and Phase 4 studies assess high-dose regimen efficacy alongside acid-reducing drug interactions. Overall, these trials encompass active, unknown, and completed recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06054464 Active not recruiting
Healthy Volunteers
PMV Pharmaceuticals Inc
 2023-09-19 Phase 1
NCT03397680 Unknown status
Helicobacter Pylori Infection
Thammasat University
 2017-05-15 Phase 1
NCT02605395 Completed
Gastrointestinal Diseases
GlaxoSmithKline
 2014-03-22 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rabeprazole selectively binds to and inhibits the gastric H+/K+-ATPase proton pump on the secretory surface of parietal cells, thereby preventing the terminal step of gastric acid secretion and raising intragastric pH. This profound inhibition of gastric acid production suppresses mucosal acid exposure, providing therapeutic efficacy in managing gastrointestinal diseases and supporting Helicobacter pylori eradication protocols.

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>).

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Note: Technical data last updated: Sep 1, 2026.