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Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Summary

The study will assess the Pharmacokinetic (PK) and safety of BGF MDI [Budesonide/glycopyrronium/formoterol (BGF) metered dose inhaler (MDI)] formulated with 2 different propellants :Hydrofluoroolefin (HFO) and Hydrofluoroalkane (HFA) with oral activated charcoal in healthy subjects (male or female).

Clinical Trial Description

This is a Phase I, randomized, double-blind, single-dose, single-center, partial-replicate, 3 way cross-over study. The study will comprise: - Screening period: up to 28 days prior to first dosing; - Three treatment periods : Subject will be resident in the Clinical Unit from the morning on the day before dosing with BGF MDI (Day 1 of Treatment Period 1), until 24 hours following the final dose (Day 2 of Treatment Period 3 a washout period of 3 to 7 days between each dose; - Follow-up: Within 3 to 7 days after the last administration of BGF MDI. Subjects will receive 3 single-dose treatments of BGF MDI [Test formulation Treatment A (BGF MDI HFO); Reference formulation Treatment B (BGF MDI HFA)] on Day 1 of each Treatment Period (1, 2, and 3) following an overnight fast of at least 8 hours. There will be a washout period of 3 to 7 days between each dose. Each subjects will be involved in the study for up to 55 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05477108
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date July 29, 2022
Completion date April 11, 2023
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