Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514157
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-05-29
Brief Title:
Phase I PK Study of BudesonideAlbuterol Delivered From PT027 in Healthy Chinese Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Open-Label Single-dose Single Arm Study to Evaluate the Pharmacokinetics Safety and Tolerability of Budesonide and Albuterol Delivered by PT027 in Healthy Chinese Participants
Status:
COMPLETED
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:
PUTUO
Brief Summary:
A phase I study to assess the PK safety and tolerability of budesonide and albuterol delivered from a single dose of BDA MDI administered by inhalation in healthy Chinese participants
Detailed Description:
This is a Phase I single centre single arm open-label study to gather information on the PK safety and tolerability of budesonide and albuterol delivered from BDA MDI after single dose administration in healthy Chinese male and female participants Approximately 14 healthy Chinese participants aged 18 to 55 years will be assigned to study intervention
The study will comprise
A screening period of minimum 2 days and maximum 27 days Inpatient admission period during which participants will be resident from the day prior to administration of BDA MDI Day -1 until at least 24 hours after dosing Participants will be discharged on the morning of Day 2 The treatment will consist of a single dose of BDA MDI 160 μg180 μg administered as 2 actuations of 80 μg90 μg followed by 24 hours of plasma sampling for determination of PK parameters A Follow-up Visit within 3 to 7 days after the administration of BDA MDI
The study will comprise
A screening period of minimum 2 days and maximum 27 days Inpatient admission period during which participants will be resident from the day prior to administration of BDA MDI Day -1 until at least 24 hours after dosing Participants will be discharged on the morning of Day 2 The treatment will consist of a single dose of BDA MDI 160 μg180 μg administered as 2 actuations of 80 μg90 μg followed by 24 hours of plasma sampling for determination of PK parameters A Follow-up Visit within 3 to 7 days after the administration of BDA MDI
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