Clinical Trials

A completed Phase 1 clinical trial sponsored by Egalet Ltd evaluated the pharmacokinetic properties and drug interactions of intranasal ketorolac tromethamine and fluticasone propionate in healthy subjects. Because research remains limited to early-phase pharmacology in healthy volunteers, no Phase 2 or Phase 3 clinical trials targeting specific pathological conditions have been conducted for tromethamine hydrochloride.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01365611 Completed
Healthy Subjects
Egalet Ltd
 2007-02 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trometamol hydrochloride acts as an organic amine proton acceptor that binds free hydrogen ions and dissolved carbon dioxide in biological fluids, thereby neutralizing excess acidity and preventing acid-induced cellular damage. By rapidly counteracting metabolic acid accumulation and restoring physiological pH balance, this buffering action stabilizes systemic acid-base regulation, providing therapeutic utility in managing acidaemia and supporting pharmacokinetic evaluations in healthy subjects.

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.