Research Site
Glendale, California, 91206, United States
NCT Number: NCT06139991
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Glendale, California, 91206, United States
Eligible participant will receive 3 single-dose treatments; 2 doses of BDA MDI HFA and 1 dose of BDA MDI HFO.
The study will comprise of:
Each participant has to be involved in the study for up to 48 days.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
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)
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)
The AUCinf after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
The Tmax after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
The T1/2λz after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
The MRT after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
The CL/F after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
The Vz/F after administration of budesonide and albuterol will be evaluated.
Time frame: Day 1, Day 2 (pre-dose and post-dose)
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)
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)
The ratio of Treatment A (test formulation) and Treatment B (reference formulation) AUClast values 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)
The safety and tolerability of single doses of BDA MDI HFO and BDA MDI HFA will be evaluated.
AstraZeneca
Industry
A Phase 1, Randomized, Double-blind, Single-dose, Partial Replicate, 3-period Cross-over Study to Assess the Total Systemic Exposure Bioequivalence of Budesonide and Albuterol Delivered by BDA MDI Hydrofluoroolefin (HFO) Compared With BDA MDI (Hydrofluoroalkene) HFA.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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