A Randomized, Open-Label, Single-Center, Crossover Study of the Potential Effects of Paroxetine on the Pharmacokinetics of a Single Dose of Paliperidone Extended-Release in Healthy Men

A Randomized, Open-Label, Single-Center, Crossover Study of the Potential Effects of Paroxetine on the Pharmacokinetics of a Single Dose of Paliperidone Extended-Release in Healthy Men - DDI-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29906

Enrollment

Registered

2006-03-31

Start date

2006-04-04

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

Healthy Volunteers Not applicable

Interventions

All subjects will receive each of the following 2 treatments in the order specified by random assignment: Treatment A: One tablet of 3-mg paliperidone ER in fasted state. Treatment B: One 20-mg parox

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects, aged 18-55 years, inclusive Extensive metabolizer of CYP2D6. Subjects whose CYP2D6 genotype is unknown should have been phenotyped before the start of the study.

Exclusion criteria

Exclusion criteria: Relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease Known history of drug-induced dystonia

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic blood- and urine investigation, adverse events reporting, safety laboratory parameters, vital signs, heart rate, ECG and alcohol breath test.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)