A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Subjects With Schizophrenia

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-001845-40

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Extrait

The primary objectives of this study are to evaluate the safety and tolerability of: a). the deltoid muscle injection site for initiating treatment with any of 3 doses of paliperidone palmitate (50, 75, and 100 mg eq.) in subjects with schizophrenia. · b). switching from the gluteal to the deltoid injection site and from the deltoid to the gluteal injection site at therapeutic plasma concentrations with 3 doses of paliperidone palmitate (50, 75, and 100 mg eq.) in subjects with schizophrenia.


Critère d'inclusion

  • Schizophrenia according to DSM-IV-TM [disorganized type (295.10), catatonic type (295.20), paranoid type (295.30), residual type (295.60) or undifferentiated type (295.90)]