drugset / Trial / NCT06128954

Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).

NCT06128954

Phase 1 Completed 26 enrolled Orphalan
RandomizedCrossoverOpen-labelTreatment

Summary

A randomised, open-label study evaluating the pharmacokinetics, safety, and tolerability of a new once daily dose of 900mg of TETA 4HCL by comparing it against the current marketed Cuprior® formulation (450mg trientine base, twice daily) in healthy male and female participants.

Timeline

Start
2024-01-16
Primary completion
2024-02-08
Completion
2024-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject trientine Unknown 450 mg
Subject trientine Unknown 900 mg

Indications