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.
Phase of Trial: Phase I
Latest Information Update: 20 Sep 2017
At a glance
- Drugs Paliperidone (Primary)
- Indications Schizoaffective disorder; Schizophrenia
- Focus Pharmacokinetics
- Sponsors Janssen Research & Development
- 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.