Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340581
Status:
WITHDRAWN
Last Update Posted:
2024-07-05
First Post:
2024-03-25
Brief Title:
A Study to Assess the Lung Exposure Bioequivalence of Budesonide Glycopyrronium Formoterol BGF Metered Dose Inhaler MDI Hydrofluoroolefin HFO With a Spacer Treatment B BGF MDI Hydrofluoroalkane HFA With a Spacer Treatment A as Well as BGF MDI HFO Without a Spacer Treatment C
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Randomized Partial Double-blind Single Dose 3 Way Cross Over Study to Assess the Lung Exposure Bioequivalence of Budesonide Glycopyrronium and Formoterol for BGF MDI HFO Compared With BGF MDI HFA Using an AeroChamber Plus Flow Vu Spacer and to Compare the Lung Exposure of BGF MDI HFO With a Spacer to BGF MDI HFO Without a Spacer
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study no longer required
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to demonstrate the equivalence of budesonide glycopyrronium formoterol BGF metered dose inhaler MDI hydrofluoroolefin HFO with a spacer to BGF MDI hydrofluoroalkane HFA with a spacer The secondary objective is to characterize BGF MDI HFO with and without a spacer
Detailed 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
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 as a single dose 4 inhalations Treatment A BGF MDI HFA with AeroChamber Plus Flow-Vu spacer with charcoal reference formulation Treatment B BGF MDI HFO with AeroChamber Plus Flow-Vu spacer with charcoal - test formulation and Treatment C BGF MDI HFO 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
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
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 as a single dose 4 inhalations Treatment A BGF MDI HFA with AeroChamber Plus Flow-Vu spacer with charcoal reference formulation Treatment B BGF MDI HFO with AeroChamber Plus Flow-Vu spacer with charcoal - test formulation and Treatment C BGF MDI HFO 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509914-12 | OTHER | EU CT | None |