NCT03934333

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

A Phase 1, Randomized, Open-label, Single-dose, 2-way Cross-over Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 Compared With Pulmicort Flexhaler (ELBRUS)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is to compare the systemic exposure of budesonide delivered by the combination inhaler (budesonide/albuterol sulfate pressurized inhalation suspension \[BDA metered dose inhaler {BDA MDI}\]) with Pulmicort Flexhaler dry-powder inhaler (DPI).

Detailed description

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.

Conditions

• Relative Bioavailability

Interventions

Type	Name	Description
DRUG	BDA MDI 160/180 mcg	Budesonide/albuterol sulfate pressurized inhalation suspension, single dose given as 2 inhalations of 80/90 mcg.
DRUG	Pulmicort Flexhaler 180 mcg	Pulmicort Flexhaler aerosol, power, single-dose given as 2 inhalations of 90 mcg.

Timeline

• Start date: 2019-05-16
• Primary completion: 2019-09-10
• Completion: 2019-09-10
• First posted: 2019-05-01
• Last updated: 2019-10-01

Locations

1 site across 1 country: United States