Open-Label Study to Evaluate the Safety and Pharmacokinetics of Single-and Multiple-Dose Extended-Release OROS Paliperidone in Pediatric Subjects (>/= 10 to </= 17 Years of Age) with Schizophrenia, Sc...

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Reference: EUCTR2005-005343-26

Open-Label Study to Evaluate the Safety and Pharmacokinetics of Single-and Multiple-Dose Extended-Release OROS Paliperidone in Pediatric Subjects (>/= 10 to </= 17 Years of Age) with Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

Woman and Man

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Extract

To characterize the pharmacokinetics of paliperidone after single-dose administration and at steady state following multiple oral administrations of paliperidone ER (using population PK modeling), in children and adolescent subjects (10 to 17 years of age) with schizophrenia, schizoaffective disorder, or schizophreniform disorder.


Inclusion criteria

  • Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder