A Study to Evaluate the Amount of Drug That Becomes Available to the Blood Circulation When Inhaled by a Nebulizer and Dry Powder Inhaler in Healthy Subjects

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
This study will be an open‐label, randomised, 3 period, 3‐treatment, crossover study in healthy subjects (males and females), performed at a single clinical unit. The study will comprise: ‐ A screening period of maximum 28 days; ‐ Three treatment periods during which subjects will be resident from the morning (fasting conditions) of the day before dosing with AZD7594 (Day ‐1) until at least 48 hours after dosing; discharged on the morning of Day 3; ‐ Two ambulatory visits (Day 4 and Day 5) within each treatment period; and ‐ A final visit 10 to 14 days after the last administration of AZD7594. ‐ There will be a minimum washout period of 10 days between each dose administration. A total of 24 subjects will be randomised to receive single doses of AZD7594 on 3 occasions, under fasted conditions (overnight fast of at least 10 hours): ‐ Treatment A: 0.7 mg (delivered dose) AZD7594 via nebulizer, test ‐ Treatment B: 1.6 mg (delivered dose) AZD7594 via nebulizer, test ‐ Treatment C: 720 μg (delivered dose) AZD7594 via dry powder inhaler (DPI), reference Each subject will be involved in the study for approximately 10 to 12 weeks.
Epistemonikos ID: e0fb7ab44f3b04cb6a36111dcdbc0ded976eabbf
First added on: May 22, 2024