A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I Disorder

Phase 1 Completed 64 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purposes of this study are to evaluate the effects of a potent metabolic enzyme inducer, carbamazepine, on the steady-state pharmacokinetics of orally administered paliperidone ER and to evaluate the safety and tolerability of the treatments in clinically stable patients with a diagnosis of schizophrenia or bipolar I disorder.

Timeline

Start: 2006-09
Primary completion: —
Completion: 2007-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carbamazepine	Small molecule	200 mg	Oral
Subject	Paliperidone	Unknown	6 mg	Oral

A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I Disorder

Summary

Timeline

Drugs

Indications