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
- Registration Number
- NCT02184767
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ADASUVE® ADASUVE® oral inhalation using a single-use, hand-held, inhaler; dosage determined by the investigator according the participants weight
- Primary Outcome Measures
Name Time Method area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t) 48 hours
- Secondary Outcome Measures
Name Time Method time to maximum observed concentration (tmax) 48 hours maximum observed plasma drug concentration (Cmax) 48 hours volume of distribution (V/F) 48 hours area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) 48 hours ratio of AUC0-t to AUC0-inf (AUC0-t/AUC0-inf) 48 hours The palatability of ADASUVE will be performed using a visual analog scale (VAS) 2 1/2 weeks apparent terminal elimination rate constant (Kel) 48 hours elimination half-life (t½) 48 hours apparent clearance (CL/F) 48 hours Summary of participants with adverse events 3 weeks
Trial Locations
- Locations (2)
Teva Investigational Site 12468
🇺🇸Atlanta, Georgia, United States
Teva Investigational Site 12469
🇺🇸Cincinnati, Ohio, United States