Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents

Phase 1 Completed 21 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.

Timeline

Start: 2004-07-01
Primary completion: 2005-07-01
Completion: 2005-07-01

Publications

Findling RL, Kauffman RE, Sallee FR, Carson WH, Nyilas M, Mallikaarjun S, Shoaf SE, Forbes RA, Boulton DW, Pikalov A. Tolerability and pharmacokinetics of aripiprazole in children and adolescents with psychiatric disorders: an open-label, dose-escalation study. J Clin Psychopharmacol. 2008 Aug;28(4):441-6. doi: 10.1097/JCP.0b013e31817dd520.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aripiprazole	Other / unclassified	20 mg	Oral
Subject	Aripiprazole	Other / unclassified	25 mg	Oral
Subject	Aripiprazole	Other / unclassified	30 mg	Oral

Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents

Summary

Timeline

Publications

Drugs

Indications