A Phase 1 interventional study of Treatment A: BGF MDI HFO and Treatment B: BGF MDI HFA in Healthy Participants, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.
This is a Phase I, randomized, double-blind, single-dose, single-site, three way cross-over study to assess the pharmacokinetic (PK) and safety of BGF MDI with HFO propellant compared with BGF MDI with HFA propellant in healthy participants (male or female).
The study will comprise of:
Participants will receive all the treatments as a single dose (2 inhalations) (Treatment A [BGF MDI HFO - test formulation], and Treatment B [BGF MDI HFA - reference formulation]) in one of the 3 possible treatment sequences: ABB, BAB, or BBA. Each participant will be involved in the study for up to 52 days.
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive single doses (2 inhalations as a single dose) of test formulation BGF MDI HFO
Drug: Treatment A: BGF MDI HFO
Participants will receive single doses (2 inhalations as a single dose) of reference formulation BGF MDI HFA
Drug: Treatment B: BGF MDI HFA
Participants will receive 2 inhalations of BGF MDI HFO (Budesonide/glycopyrronium/fomoterol fumarate pressurized inhalation suspension 160/14.4/4.8 μg per actuation) as a single dose via oral inhalation administered during 1 Treatment period.
Also known as: Budesonide/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFO
Participants will receive 2 inhalations of BGF MDI HFA (Budesonide/glycopyrronium/fomoterol fumarate pressurized inhalation suspension 160/14.4/4.8 μg per actuation) as a single dose via oral inhalation administered during 2 Treatment periods.
Also known as: Budesonide/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFA
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Maximum observed drug concentration (Cmax)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Area under concentration time curve from time 0 to infinity (AUCinf)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Extrapolated area under the curve from time of last quantifiable concentration (tlast) to infinity, expressed as percentage of AUCinf (AUCextr)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Time to reach maximum observed concentration (tmax)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Terminal rate constant (λz)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Terminal elimination half-life (t1/2λz)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Apparent total body clearance (CL/F)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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