Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595121
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Bioequivalence of IMP 08P1707F0 Relative to Pulmicort 10 Mg2 Ml Suspension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Bioavailability Study of Budesonide After Inhalation of Budesonide 1 Mg 2 Ml Nebuliser Suspension Test Product 08P1707F0 Administration Without and with Activated Charcoal and Inhalation of Pulmicort 10 Mg 2 Ml Suspension Reference Product in Healthy Subjects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUNIPILOT
Brief Summary:
This study aims to demonstrate the bioequivalence between the formulation of Budesonide 1mg2mL nebuliser suspension IMP 08P1707F0 relaive to the reference product Pulmicortr 10mg2mL suspension
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None