Clinical Trials

Several clinical trials evaluating ranitidine hydrochloride have reached completed status, encompassing Phase I protocols and studies with non-applicable phase classifications. Sponsored by entities such as Universidad Miguel Hernandez de Elche, Sanofi, and Biogen, these protocols investigated advanced solid tumors, medullary thyroid cancer, and critical care or cardiovascular emergencies. Across these studies, research focused on pharmacokinetic profiles, antacid interactions in cancer settings, and supportive nursing interventions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05399927 Completed
Music Therapy|Cardiovascular Diseases|Critical Care|Emergencies
Universidad Miguel Hernandez de Elche
 2015-07 Not Applicable
NCT01539655 Completed
Medullary Thyroid Cancer
Sanofi
 2012-02 Phase 1
NCT01017198 Completed
Advanced Solid Tumors
Biogen
 2009-11 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ranitidine hydrochloride selectively binds to and antagonizes histamine H2 receptors on gastric parietal cells, thereby blocking histamine-stimulated intracellular signaling pathways and suppressing gastric acid secretion. This elevation in intragastric pH prevents acid-induced mucosal damage and modulates pH-dependent drug absorption, providing therapeutic utility in gastric acid management and in clinical trials evaluating pharmacokinetic interactions in patients with advanced solid tumors and medullary thyroid cancer.

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.