Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531811
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
A Study to Investigate the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Open-label Single-dose 2-Treatment 2-Period Crossover Study to Assess the Relative Bioavailability of AZD8630 Following a Device and Formulation Transition in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2024-10
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:
None
Brief Summary:
The purpose of this study is to evaluate the potential difference between pharmacokinetics PK safety tolerability and device performance between the AZD8630 test formulation and the AZD8630 reference formulation
Detailed Description:
This is a randomized open-label 2- treatment 2- period study with a duration of approximately 6 weeks
The Study will comprise of
A Screening period of 28 days
Treatment Period 1 on Day 1 and Treatment Period 2 on Day 9
A Follow-up visit within 7 days 2 days after the last dose in Period 2
Participants will be randomized 11 to either Sequence 1 or Sequence 2
Sequence 1 Treatment A AZD8630 Monodose inhalation powder crossover to Treatment B AZD8630 test inhalation powder
Sequence 2 Treatment B AZD8630 test inhalation powder crossover to Treatment A AZD8630 Monodose inhalation powder
The Study will comprise of
A Screening period of 28 days
Treatment Period 1 on Day 1 and Treatment Period 2 on Day 9
A Follow-up visit within 7 days 2 days after the last dose in Period 2
Participants will be randomized 11 to either Sequence 1 or Sequence 2
Sequence 1 Treatment A AZD8630 Monodose inhalation powder crossover to Treatment B AZD8630 test inhalation powder
Sequence 2 Treatment B AZD8630 test inhalation powder crossover to Treatment A AZD8630 Monodose inhalation powder
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