Clinical Trials

Multiple completed clinical trials have evaluated olmesartan, including commercially sponsored Phase 1 studies assessing its pharmacokinetics, bioequivalence, and safety in healthy volunteers. Additionally, several observational studies supported by academic and governmental institutions examined drug-metabolizing enzyme and transporter dynamics in patients with chronic kidney disease and vitamin D deficiency. These efforts provided critical insight into the drug’s metabolic disposition and safety across diverse populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05017987 Completed
Healthy Adult Volunteers
Autotelicbio
 2021-06-19 Phase 1
NCT03951051 Completed
Bioequivalence
Pharmtechnology LLC|Altasciences Company Inc.
 2019-05-06 Phase 1
NCT02360644 Completed
Chronic Kidney Diseases|Deficiency Vitamin D
University of Colorado Denver|University of Pittsburgh|National Institute of General Medical Sciences (NIGMS)
 2014-10 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olmesartan selectively binds to the angiotensin II type 1 (AT1) receptor, blocking downstream angiotensin II-mediated intracellular signaling and inhibiting vascular smooth muscle contraction as well as aldosterone secretion. This inhibition attenuates systemic vascular resistance and reduces blood pressure, providing the biochemical basis for its evaluation in clinical trials assessing bioequivalence and therapeutic applications in chronic kidney disease.

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.