drugset / Trial / NCT05322707

BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient

NCT05322707

Phase 3 Completed 1485 enrolled Cipla Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma

Timeline

Start
2022-04-15
Primary completion
2023-08-15
Completion
2023-08-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 80 ug Inhaled
Subject Formoterol Other / unclassified 4.5 ug Inhaled
Comparator Symbicort Unknown Inhaled

Indications