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
The planned duration for this trial is approximately 1.5 to 3 months. The trial includes a 14-day screening period, 3 treatment periods (2 days each), and a follow up visit 7 days after end of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Pharmaceutical form: Dry powder Route of administration: Oral inhalation
Pharmaceutical form: Dry powder Route of administration: Oral inhalation
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
Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp)
Time frame: Up to 24 hours postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS)
Time frame: Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp
Time frame: Up to 24 hours postdose
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 frame: Up to 24 hours postdose
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Fluticasone Propionate
Time frame: Up to 24 hours postdose
AUC0-24 of Albuterol Sulfate
Time frame: Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp
Time frame: Up to 24 hours postdose
Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS
Time frame: Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp
Time frame: Up to 24 hours postdose
Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS
Time frame: Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of Fp
Time frame: Up to 24 hours postdose
Last Measurable Concentration Above the Quantification Limit (Clast) of ABS
Time frame: Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of Fp
Time frame: Up to 24 hours postdose
Time of Last Measurable Concentration (tlast) of ABS
Time frame: Up to 24 hours postdose
Number of Participants with Adverse Events (AEs)
Time frame: Up to 2 Months
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 2 Months
Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 2 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.