A Study to Compare the Pharmacokinetics of Budesonide and Albuterol Delivered by PT027 Compared With PT007 and PT008 Administered Separately

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
This study will be a randomized, 3‐way cross‐over study in healthy male and female participants, performed at a single study centre. A total of 90 healthy male or female participants will be randomized in this study to ensure that at least 81 participants are evaluable. The study will comprise: A screening period of maximum 27 days; Three treatment periods during which participants will be resident from the morning before dosing with Budesonide/Albuterol Sulfate metered dose inhaler (BDA MDI), Budesonide metered dose inhaler (BD MDI), and Albuterol Sulfate metered dose inhaler (AS MDI [Day ‐1]) until at least 24 hours after dosing; discharged on the morning of Day 2; and A final visit within 5 to 7 days after the last administration of BDA MDI, BD MDI, or AS MDI. There will be a minimum washout period of 7 days between each dose administration.
Epistemonikos ID: 97df3302632249c013b06d20312b08bd3a82e0af
First added on: May 21, 2024