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

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 - GMPO-131-001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42700

Enrollment

Registered

2015-06-04

Start date

2015-06-09

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

excessive copper accumulation Wilsons disease

Interventions

Single dose of 900 mg of TETA•2HCl (i.e. 3 capsules of 300 mg containing each 225 mg of trientine base) or 1200 mg TETA•4HCl (i.e. 4 tablets of 300 mg containing each 150 mg of trientine base) will

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female volunteers aged 18 to 45 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To assess and compare the plasmatic PK profiles of single doses of trientine dichlorhydrate (TETA•2HCl) and trientine tetrachlorhydrate (TETA•4HCl) in adult heathy volunteers.	—

Secondary

Measure	Time frame
Safety analyses will be conducted on all subjects who have received at least one dose of TETA•2HCl or TETA•4HCl	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)