This study will investigate the Pharmacokinetic (PK) and safety of Budesonide and albuterol (BDA) metered dose inhaler (MDI) HFO and BDA MDI HFA in healthy male and female participants.
Eligible participant will receive 3 single-dose treatments; 2 doses of BDA MDI HFA and 1 dose of BDA MDI HFO. * Treatment A: 2 inhalations, single dose of BDA MDI HFO 80/90 μg (test formulation) * Treatment B: 2 inhalations, single dose of BDA MDI HFA 80/90 μg (reference formulation) Participants will be randomly assigned to receive any 1 of the 3 treatment sequences of ABB, BBA or BAB. The study will comprise of: * A screening period of maximum 28 days. * Three Treatment periods will be up to approximately 22 days (including Follow-up). * A final follow-up calls within 3-7 days after the last dose of study intervention. Each participant has to be involved in the study for up to 48 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
66
Randomized participants will receive Treatment A (BDA MDI HFO) on Day 1 under fasted condition.
Randomized participants will receive Treatment B (BDA MDI HFA) on Day 1 under fasted condition.
Research Site
Glendale, California, United States
Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
The AUClast of budesonide and albuterol will be evaluated to assess the bioequivalence of the total systemic exposure of budesonide and albuterol administered.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Maximum plasma drug concentration (Cmax)
The Cmax of budesonide and albuterol will be evaluated to assess the bioequivalence of the total systemic exposure of budesonide and albuterol administered.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
The AUCinf after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Time to reach maximum observed concentration (Tmax)
The Tmax after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Terminal elimination half-life (T1/2λz)
The T1/2λz after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)
The MRT after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Apparent total body clearance (CL/F)
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The CL/F after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Apparent volume of distribution during the terminal phase (Vz/F)
The Vz/F after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Ratio Maximum plasma drug concentration (Cmax)
The ratio of Treatment A (test formulation) and Treatment B (reference formulation) Cmax values will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Ratio Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
The ratio of Treatment A (test formulation) and Treatment B (reference formulation) AUCinf values will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Ratio Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
The ratio of Treatment A (test formulation) and Treatment B (reference formulation) AUClast values will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Number of participants with Adverse Events
The safety and tolerability of single doses of BDA MDI HFO and BDA MDI HFA will be evaluated.
Time frame: From Screening (≤ 28 days to Day -2) until Follow-up phone call (within 3 to 7 days post final dose)