Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 11:57 AM
Study NCT ID:
NCT06723756
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2024-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
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 in Healthy Adult Participants
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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:
* A Screening period of up to 27 days;
* Three Treatment periods: Participants will receive a single dose of the study intervention on three separate occasions (Period 1, Period 2 and Period 3), with the final dose on Day 2 of Treatment Period 3, and a washout period of 5 to 7 days between administration of each dose;
* A final Safety Follow-up within 5 to 7 days after the last administration of the study intervention in Treatment Period 3.
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.
The study will comprise of:
* A Screening period of up to 27 days;
* Three Treatment periods: Participants will receive a single dose of the study intervention on three separate occasions (Period 1, Period 2 and Period 3), with the final dose on Day 2 of Treatment Period 3, and a washout period of 5 to 7 days between administration of each dose;
* A final Safety Follow-up within 5 to 7 days after the last administration of the study intervention in Treatment Period 3.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: