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COMPLETED
NCT06290102
PHASE1

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.

View on ClinicalTrials.gov

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

DRUG

TEV-56248

Pharmaceutical form: Dry powder Route of administration: Oral inhalation

DRUG

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