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
32
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Other
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
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.
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 1:1 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).
Location
Location
Baltimore, MD, United States, 21225
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. |
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