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
NCT02184767 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2021-11-12
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
Interventions
- DRUG
-
ADASUVE®
ADASUVE® 2.5, 5, or 10 mg
Sponsors & Collaborators
-
Teva Branded Pharmaceutical Products R&D, Inc.
lead INDUSTRY
Principal Investigators
-
Sponsor Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 10 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2015-03-31
- Completion
- 2015-05-31
Countries
- United States
Study Locations
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