drugset / Trial / NCT03934333

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

NCT03934333

Phase 1 Completed 11 enrolled AstraZeneca
RandomizedCrossoverOpen-labelTreatment

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).

Timeline

Start
2019-05-16
Primary completion
2019-09-10
Completion
2019-09-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 160 ug Inhaled
Subject Budesonide Small molecule 180 ug Inhaled
Background Salbutamol Unknown 180 ug Inhaled

Indications

No indication recorded.