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.
Completed
- Conditions
- hepatolenticular degenerationWilson's disease10083624
- Registration Number
- NL-OMON46237
- Lead Sponsor
- nivar BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Healthy male or female subjects;Females must not be pregnant or breastfeeding and must be postmenopausal or agree to use an acceptable form of birth control;Aged 18 to 75 years inclusive at screening.;For more inclusion criteria a reference is made to the protocol.
Exclusion Criteria
Has smoked more than 5 cigarettes or equivalents tobacco products per day within 14 days prior to the first dose of study medication.;History or presence of drug or alcohol abuse within the past 5 years. ;For more exclusion criteria a reference is made to the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PK: Cmax, AUC0-t, AUC0-*, Tmax, t1/2 and Kel for trientine.</p><br>
- Secondary Outcome Measures
Name Time Method <p>PK: Cmax, AUC0-t, AUC0-*, Tmax, t1/2 and Kel for MAT and DAT<br /><br>PD (for treatments A and C only): urinary copper excretion, serum copper and<br /><br>ceruloplasmin<br /><br>Safety: AEs (clinical relevant changes in VS, ECGs and laboratory parameters<br /><br>should be reported as AEs)</p><br>