A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Paliperidone Palmitate 3-Month Formulation in Subjects With Schizophrenia.

Trial Profile

A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Paliperidone Palmitate 3-Month Formulation in Subjects With Schizophrenia.

Completed
Phase of Trial: Phase I

Latest Information Update: 06 Mar 2017

At a glance

  • Drugs Paliperidone (Primary)
  • Indications Schizoaffective disorder; Schizophrenia
  • Focus Pharmacokinetics
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 14 Oct 2016 Results of retrospective analysis of pooled data of this and other two trials (NCT01515423, NCT01529515) to characterize the population pharmacokinetics of paliperidone published in the Clinical Pharmacokinetics
    • 22 Jun 2016 Results assessing Phase III dose selection (see profile 212758) based on the data from a 6-month interim analysis of this trial published in the British Journal of Clinical Pharmacology
    • 20 May 2015 Results presented at the 168th Annual Meeting of the American Psychiatric Association.
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