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
- Completed
- 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.
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Child
- Age Range
- 4 Years to 11 Years
- Trial Duration
- May 07, 2024 - October 07, 2024
- Phase
- Phase 1
