COPD Clinical Trial
Official title:
OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, SINGLE DOSE STUDY IN HEALTHY VOLUNTEERS TO INVESTIGATE THE PHARMACOKINETICS OF CHF 6001 DPI ADMINISTERED USING THE MULTI-DOSE RESERVOIR NEXThaler® DEVICE OR THE CAPSULE FOR ORAL INHALATION VIA AEROLIZER® DEVICE
The purpose of this study is to compare the systemic availability to CHF 6001 after a single
dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose
capsule inhaler Aerolizer®.
CHF 6001 is an antinflammatory drug under development for Chronic obstructive pulmonary
disease (COPD) therapy. The drug is presented as dry powder for inhalation delivered by an
inhaler device. Previous studies were conducted using a single-dose capsule inhaler
(Aerolizer®) device. For the subsequent clinical studies a novel multi-dose NEXThaler®
device will be used.
This is an Open-label, randomized, 2-way cross-over, Phase I study. The study is conducted in 1 single european site. The main scope of the study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 DPI administered using the multi-dose reservoir NEXThaler® device or the single-dose capsule Aerolizer® device. ;
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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