A single-dose, open label, randomized, three-way cross-over study in healthy volunteers to characterize the pharmacokinetics of the 300 mg trientine capsule and to assess the effect of dissolution rate and the effect of food on the pharmacokinetics of trientine.

Wilson's disease (WD) is a rare autosomal recessive condition caused by
mutations of the ATP7B gene, a gene that encodes for the Wilsons protein, a
metal-transporting P-type adenosine triphosphate (P-type ATP) (Ala et al 2007).
First symptoms of WD symptoms usually appear between the ages of 6 and 20 years
and males and females are equally affected. WD occurs in approximately 1 to 4
per 100,000 people (Ala et al 2007). The therapy is aimed to reduce the serum
copper levels by reducing the intake with a low copper diet, reducing the
copper absorption by treatment with zinc acetate, and by the use of chelating
agents such as D-penicillamine and trientine dihydrochloride that bind the free
copper and facilitate its excretion from the body. Early diagnosis and
life-long treatment is important to prevent serious long-term disability and
life threatening complications.

Primary objectives:
To characterize the pharmacokinetics of the 300 mg trientine capsule with a
fast dissolution profile.
To assess the effect of dissolution rate on the pharmacokinetics of trientine.
To assess the effect of food on the pharmacokinetics of trientine.

Secondary objectives:
To assess the pharmacokinetics of the metabolites of trientine after
administration of trientine capsules with different dissolution rates and in
fed and in fasted conditions.
To assess and compare the pharmacodynamics after administration of trientine
capsules with different dissolution rates.
To assess and compare the safety and tolerability after administration of
trientine capsules with different dissolution rate and in fed and fasted
conditions.

A single dose, open label, randomized, two-way cross-over study in healthy
volunteers.

Trientine dihydrochloride 300 mg capsule.

The dosage levels of the study drug are based on a previous clinical trial
conducted by the sponsor. The risk to health at the chosen
dose is limited, but the patients may experience any of the side effects in the
ICF or symptoms that have not been reported before.
Volunteers health is closely monitored during the study to minimize these
risks. If the volunteers experience side effects, the
investigator will treat them where necessary. If new information is available
on the safety of the study medication, the volunteers are
informed as soon as possible. The blood collection procedure is not dangerous.