Asthma Clinical Trial
Official title:
An Open-label, Single-centre, Randomised, 3-period, 3-treatment, Single-dose, Crossover Study to Assess the Relative Bioavailability of AZD7594 Inhaled Via a Nebulizer and Via a Dry Powder Inhaler in Healthy Subjects
The purpose of this study is to assess the relative bioavailability of the AZD7594 nebulized
formulations (test) and the dry powder formulation (reference).
The study results will provide information on the pharmacokinetic (PK) profile following use
of the 2 devices to be used in further clinical development.
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.
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