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 Me

• Conditions: Healthy Volunteers; Not applicable; 10039628

• Registration Number: NL-OMON29906
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic blood- and urine investigation, adverse events reporting,<br /><br>safety laboratory parameters, vital signs, heart rate, ECG and alcohol breath<br /><br>test.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not Applicable</p><br>