Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects With Schizophrenia

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the pharmacokinetic parameters (blood concentrations) of i.m. paliperidone palmitate after administration in 2 different injection sites (deltoid or gluteal).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Patients with a diagnosis of schizophrenia

• clinically stable with no change in current antipsychotic medications

• meet PANSS score criteria

• have a body mass index (BMI) between 15 and 35 kilogram (kg)/meter (m)2.

Exclusion Criteria:

• Patients with DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence

• involuntarily-committed

• have moderately severe or severe EPS symptoms

• history of malignant neuroleptic syndrome

• have current suicidal ideation or demonstrates violence

• current presence of any significant or unstable medication condition

• treatment with any protocol disallowed therapies

• clinically significant result from screening laboratory or ECG.