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Clinical Trial Summary

The purpose of this study is to assess the bioequivalence of the lung exposure of budesonide, glycopyrronium, and formoterol administered as budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with AeroChamber Plus Flow-Vu spacer compared with BGF MDI hydrofluoroalkane (HFA) with AeroChamber Plus Flow Vu spacer And BFG MDI HFO (Spacer vs No Spacer).

Clinical Trial Description

This study is a Phase I, randomized, partial double-blind, single dose, single-center, 3-way cross over study to assess the pharmacokinetic (PK) and safety of BGF MDI in healthy participants (male or female). The study will comprise: 1. A Screening Period of up to 27 days prior to first dosing. 2. Three treatment periods: Participants will be resident at the Clinical Unit from Day -1 until 24 hours after dosing with the final treatment, with a washout period of 3 to 7 days between each dose administration. 3. Follow-up: A final Follow-up Phone Call within 5 to 7 days after the last administration of BGF MDI in Treatment Period 3. Participants will receive all 3 treatments (Treatment A [BGF MDI HFA ex-actuator; as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal, reference formulation], Treatment B [BGF MDI HFO ex-actuator; as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal - test formulation], and Treatment C [BGF MDI HFO ex-actuator; as a single dose without spacer with charcoal]) (1 treatment per treatment period) in one of 6 possible treatment sequences; ABC, ACB, BAC, BCA, CAB, or CBA. There will be a 3 to 7 days washout period between each dose administration. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT06340581
Study type Interventional
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Status Not yet recruiting
Phase Phase 1
Start date June 17, 2024
Completion date October 28, 2024

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