TRIENTINE DIHYDROCHLORIDE VS. TETRAHYDROCHLORIDE: A PHASE 1, SINGLE CENTER, RANDOMIZED, INTERVENTIONAL, SINGLE DOSE, OPEN-LABEL, CROSSOVER STUDY IN ADULT HEALTHY MALE AND FEMALE SUBJECTS TO EVALUATE THE PHARMACOKINETICS AND THE SAFETY, TOLERABILITY OF TWO DIFFERENT ORAL FORMULATIONS
Completed
- Conditions
- excessive copper accumulationWilsons disease10022958
- Registration Number
- NL-OMON42700
- Lead Sponsor
- GMP-Orphan SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
Inclusion Criteria
Healthy male and female volunteers aged 18 to 45 years
Exclusion Criteria
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study, including bowel, gastrointestinal, renal, pulmonary, pancreatic, hepatic, hematological, immunological, or neurological disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess and compare the plasmatic PK profiles of single doses of trientine<br /><br>dichlorhydrate (TETA•2HCl) and trientine tetrachlorhydrate<br /><br>(TETA•4HCl) in adult heathy volunteers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety analyses will be conducted on all subjects who have received at least<br /><br>one dose of TETA•2HCl or TETA•4HCl</p><br>