Clinical Trial Simulations and Pharmacometrics Analysis in Pediatrics: Application to Inhaled Loxapine in Children and Adolescents

摘要

Background and ObjectivesLoxapine for inhalation is a drug-device combination product approved in adults for the acute treatment of agitation associated with schizophrenia or bipolar I disorder. The primary objective of this study was to develop a clinical trial protocol to support a phase I pharmacokinetics (PK) study in children aged 10 years and older. In addition, this report details the results of the clinical study in relation to predicted likelihood of achieving target exposure associated with therapeutic effect in adults.