This study is to compare the systemic exposure of budesonide delivered by the combination inhaler (budesonide/albuterol sulfate pressurized inhalation suspension \[BDA metered dose inhaler {BDA MDI}\]) with Pulmicort Flexhaler dry-powder inhaler (DPI).
This study will be an open-label, randomized, 2-way cross-over study in healthy adult male or female participants, performed at a single study center.Participants will receive single doses of BDA MDI or Pulmicort Flexhaler on 2 occasions, under fasted conditions. There will be a minimum washout period of 3 days between each dose administration. A total of 66 participants will be randomized in this study to ensure that at least 62 participants are evaluable. The study will comprise of screening period of maximum 27 days; Two treatment periods during which participants will be resident from the day prior to administration of budesonide/albuterol sulfate pressurized inhalation suspension metered dose inhaler (BDA MDI) or Pulmicort Flexhaler (Day -1) until at least 24 hours after dosing. Participants will be discharged on the morning of Day 2; and a final follow-up visit within 5 to 7 days after the last administration of BDA MDI or Pulmicort Flexhaler.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Budesonide/albuterol sulfate pressurized inhalation suspension, single dose given as 2 inhalations of 80/90 mcg.
Pulmicort Flexhaler aerosol, power, single-dose given as 2 inhalations of 90 mcg.
Research Site
Baltimore, Maryland, United States
Area under plasma concentration-time curve from time zero to infinity (AUC) for budesonide
To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler
Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)
Area under the plasma concentration-curve from time zero to time of last quantifiable concentration [AUC(0-t)] for budesonide
To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler
Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)
Maximum observed plasma concentration (Cmax) for budesonide
To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler
Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)
Time to reach maximum observed plasma concentration (tmax)
To determine tmax for budesonide delivered by BDA MDI and Pulmicort Flexhaler
Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)
Time of last quantifiable plasma concentration (tlast)
To determine tlast for budesonide delivered by BDA MDI and Pulmicort Flexhaler
Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)
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Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)
To determine t½λz for budesonide delivered by BDA MDI and Pulmicort Flexhaler
Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)
Terminal elimination rate constant (λz)
To determine λz for budesonide delivered by BDA MDI and Pulmicort Flexhaler
Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To determine CL/F for budesonide delivered by BDA MDI and Pulmicort Flexhaler
Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
To determine Vz/F for budesonide delivered by BDA MDI and Pulmicort Flexhaler
Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)
Number of participants with adverse events and serious adverse events
To assess the safety and tolerability of BDA MDI and Pulmicort Flexhaler
Time frame: From screening (Day -27 to Day -2) to post study visit ( 5-7 days)