Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication

Summary

This study is to assess the pharmacokinetics of loxapine and will be using plasma concentration data obtained over 48 hours after administration of the study drug

Timeline

Start

2014-07

Primary completion

2015-03

Completion

2015-05

Publications

• Dong M, Fukuda T, Selim S, Smith MA, Rabinovich-Guilatt L, Cassella JV, Vinks AA. Clinical Trial Simulations and Pharmacometric Analysis in Pediatrics: Application to Inhaled Loxapine in Children and Adolescents. Clin Pharmacokinet. 2017 Oct;56(10):1207-1217. doi: 10.1007/s40262-017-0512-x.

Drugs

Indications