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Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Summary
The primary objectives of this study are: * To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \[Fp/ABS eMDPI\]) in participants with asthma * To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI) * To compare the PK profiles of ABS between the 2 different strengths of TEV-56248 The secondary objective is: • To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI
Official title: An Open Label, Single Dose, 3-Period, Crossover Study to Determine the Pharmacokinetic Profile and Safety of Fluticasone Propionate/Albuterol Sulfate (Fp/ABS) Multidose Dry Powder Inhaler With e-Module (eMDPI) Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Participants With Asthma (4 to 11 Years Old)
Key Details
Gender
All
Age Range
4 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-05-16
Completion Date
2024-10-07
Last Updated
2026-08-04
Healthy Volunteers
No
Conditions
Interventions
TEV-56248
Pharmaceutical form: Dry powder Route of administration: Oral inhalation
Fp MDPI
Pharmaceutical form: Dry powder Route of administration: Oral inhalation
Locations (10)
Teva Investigational Site 12010
Mobile, Alabama, United States
Teva Investigational Site 12003
Long Beach, California, United States
Teva Investigational Site 12007
Miami, Florida, United States
Teva Investigational Site 12005
Miami, Florida, United States
Teva Investigational Site 12002
Miami, Florida, United States
Teva Investigational Site 12008
Lafayette, Louisiana, United States
Teva Investigational Site 12011
Columbia, Missouri, United States
Teva Investigational Site 12012
Oklahoma City, Oklahoma, United States
Teva Investigational Site 12001
Boerne, Texas, United States
Teva Investigational Site 12009
San Antonio, Texas, United States