A Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 Compared With Pulmicort Flexhaler (ELBRUS)

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
This study will be an open‐label, randomized, 2‐way cross‐over study in healthy adult male or female participants, performed at a single study center.Participants will receive single doses of BDA MDI or Pulmicort Flexhaler on 2 occasions, under fasted conditions. There will be a minimum washout period of 3 days between each dose administration. A total of 66 participants will be randomized in this study to ensure that at least 62 participants are evaluable. The study will comprise of screening period of maximum 27 days; Two treatment periods during which participants will be resident from the day prior to administration of budesonide/albuterol sulfate pressurized inhalation suspension metered dose inhaler (BDA MDI) or Pulmicort Flexhaler (Day ‐1) until at least 24 hours after dosing. Participants will be discharged on the morning of Day 2; and a final follow‐up visit within 5 to 7 days after the last administration of BDA MDI or Pulmicort Flexhaler.
Epistemonikos ID: 89b43e7c68770be09d6812c89a128559be163a31
First added on: May 22, 2024