A Pharmacokinetic and Safety study comparing Fluticasone Propionate and Albuterol Sulfate to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old

Study 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)

Teva Identifier

TV56248-RES-10204

ClinicalTrials.gov Identifier

NCT06290102

Study Status

Recruiting

Trial Condition(s)

Respiratory

Interventions

Drug: TEV-56248

Study Description

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 in participants with asthma, to compare the PK profiles of Fp for different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI), and to compare the PK profiles of ABS between the 2 different strengths of TEV-56248.
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Key Participation Requirements

Gender

Female, Male

Age Range

4 Years to 11 Years

Trial Duration

May 07, 2024 - November 25, 2024

Phase

Phase 1

Study Type

Interventional