NCT05569421

A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant

A Phase I, Randomized, Double-blind, Single-dose, Partial-replicate, 3-way Cross-over Study to Assess the Total Systemic Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate bioequivalence, pharmacokinetics, safety, and tolerability of Budesonide, Glycopyrronium and Formoterol (BGF) metered dose inhaler (MDI) formulated with hydrofluoroolefin (HFO) \[Test\] and hydrofluoroalkane (HFA) \[Reference\] in healthy participants (male or female).

Detailed description

This is a Phase I, randomized, double-blind, single-dose, single-center, partial-replicate, 3 way cross-over study to assess pharmacokinetic and safety of BGF MDI when administered with different propellants, HFO (HFO-1234ze) - test and HFA (HFA-134a) - reference. The study will comprise of: * A screening period up to 28 days prior to first dosing; * Three Treatment Periods: Participants will be resident at the Clinical Unit from the morning on the day before dosing with BGF MDI on Day -1 of Treatment Period 1, until 24 hours following the final dose on Day 2 of Treatment Period 3, with a washout period of 3 to 7 days between each dose; and * Follow-up: final safety Follow-up Phone Call within 3 to 7 days after the last administration of BGF MDI in Treatment Period 3. Each participant will receive 3 single dose treatments of BGF MDI (Treatment A: BGF MDI HFO \[Test\]; Treatment B: BGF MDI HFA \[Reference\]) following an overnight fast of at least 8 hours on Day 1 of each treatment period. The reference formulation will be administered during 2 of the 3 treatment periods. There will be a minimum of a 3 to 7 day washout between administration of each treatment. Each participant will be involved in the study for approximately 55 days.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Treatment A: BGF MDI HFO	Participants will receive 4 oral inhalations as a single dose - test formulation; administered during 1 treatment period.
DRUG	Treatment B: BGF MDI HFA	Participants will receive 4 oral inhalations as a single dose - reference formulation; administered during 2 treatment periods.

Timeline

• Start date: 2022-10-11
• Primary completion: 2023-04-14
• Completion: 2023-04-14
• First posted: 2022-10-06
• Last updated: 2025-08-22
• Results posted: 2025-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study