NCT02184767

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

A Nonrandomized, Open-Label, Multicenter, Phase 1 Study to Assess the Safety and Pharmacokinetics of ADASUVE® (STACCATO® Loxapine for Inhalation) 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• BiPolar

Interventions

Type	Name	Description
DRUG	ADASUVE®	ADASUVE® 2.5, 5, or 10 mg

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-03-01
• Completion: 2015-05-01
• First posted: 2014-07-09
• Last updated: 2021-11-12

Locations

2 sites across 1 country: United States