TRIUMPH-2: Trientine dihydrochloride (Syprine® capsules) vs. tetrahydrochloride (tablets): a Phase 1, single center, randomized, interventional, open-label, 4-way crossover study in adult healthy male and female subjects to evaluate the pharmacokinetics and the safety and tolerability of 2 different oral formulations.

TRIUMPH-2: Trientine dihydrochloride (Syprine® capsules) vs. tetrahydrochloride (tablets): a Phase 1, single center, randomized, interventional, open-label, 4-way crossover study in adult healthy male and female subjects to evaluate the pharmacokinetics and the safety and tolerability of 2 different oral formulations. - CS0262 GMPO-131-003

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43154

Enrollment

Registered

2016-09-13

Start date

2016-10-03

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

excessive copper accumulation Wilson's disease

Interventions

The study will start with a screening visit. During the screening visit standard medical assessments including safety laboratory tests (blood draw, urine collection), urine drug screen, a physical e

4-way crossover

pharmacokinetics

safety

tolerability

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Male and female healthy volunteers of 18 to 45 (inclusive) years of age

Exclusion criteria

Exclusion criteria: Clinical significant abnormalities at medical research

Design outcomes

Primary

Measure	Time frame
PK parameters	—

Secondary

Measure	Time frame
Safety and tolerability	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)