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

Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp),Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS),Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp,Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS,Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp,Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS,Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp,Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS,Last Measurable Concentration Above the Quantification Limit (Clast) of Fp,Last Measurable Concentration Above the Quantification Limit (Clast) of ABS,Time of Last Measurable Concentration (tlast) of Fp,Time of Last Measurable Concentration (tlast) of ABS

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