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Clinical trial

A Phase I, Single Centre, Randomised, Interventional, Open-Label, Cross-Over Study to Evaluate the Pharmacokinetics (PK) and the Safety and Tolerability of a Total Daily Dose of 900mg of TETA 4HCL, Comparing a New Once Daily TETA 4HCL Formulation (300mg) (3x300mg Trientine Base Tablets, OD) With the Current Marketed Cuprior® Formulation (150mg) (3x150mg Trientine Base Tablets, BD) in Adult Healthy Male and Female Participants

NCT06128954 is registered in ClinicalTrials.gov with Orphalan as lead sponsor.

NCT NCT06128954
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase I, Single Centre, Randomised, Interventional, Open-Label, Cross-Over Study to Evaluate the Pharmacokinetics (PK) and the Safety and Tolerability of a Total Daily Dose of 900mg of TETA 4HCL, Comparing a New Once Daily TETA 4HCL Formulation (300mg) (3x300mg Trientine Base Tablets, OD) With the Current Marketed Cuprior® Formulation (150mg) (3x150mg Trientine Base Tablets, BD) in Adult Healthy Male and Female Participants
Lead sponsor
Orphalan
Phase
Phase 1
Overall status
Completed
Start date
January 16, 2024
Completion date
February 16, 2024
Enrollment
26 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

wilson's disease