Study identifier:D6830C00002
ClinicalTrials.gov identifier:NCT06531811
EudraCT identifier:N/A
CTIS identifier:N/A
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.
Healthy Participants
Phase 1
Yes
AZD8630 (test formulation) via test inhaler, AZD8630 (reference formulation) via Monodose inhaler
All
28
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Other
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Sequence 1 (Treatment A- Treatment B) Participants will receive Treatment A (AZD8630 Monodose inhalation powder) crossover to Treatment B (AZD8630 test inhalation powder) | Drug: AZD8630 (test formulation) via test inhaler Participants will receive AZD8630 via test inhaler. Drug: AZD8630 (reference formulation) via Monodose inhaler Participants will receive AZD8630 via Monodose inhaler. Device: Test inhaler Participants will receive AZD8630 via test inhaler. Device: Monodose inhaler Participants will receive AZD8630 via Monodose inhaler. |
Experimental: Sequence 2 (Treatment B- Treatment A) Participants will receive Treatment B (AZD8630 test inhalation powder) crossover to Treatment A (AZD8630 Monodose inhalation powder) | Drug: AZD8630 (test formulation) via test inhaler Participants will receive AZD8630 via test inhaler. Drug: AZD8630 (reference formulation) via Monodose inhaler Participants will receive AZD8630 via Monodose inhaler. Device: Test inhaler Participants will receive AZD8630 via test inhaler. Device: Monodose inhaler Participants will receive AZD8630 via Monodose inhaler. |