drugset / Trial / NCT02165046

Bioavailability Study of SYN006, Pulmicort pMDI and Meptin Air in Healthy Adult.

NCT02165046

Phase 1 Completed 24 enrolled Intech Biopharm Ltd.
RandomizedCrossoverOpen-labelTreatment

Summary

Budesonide + Procaterol HFA MDI is a novel asthma product containing both budesonide and procaterol in a single inhaler. Budesonide is a corticosteroid that treats underlying airway inflammation in asthma. Procaterol is a direct acting sympathomimetic with predominantly Beta-adrenoceptor stimulant activity selective to Beta-2 receptors (a Beta-2 agonist). It is used as a bronchodilator in the management of reversible airways obstructive pulmonary disease. Budesonide and Procaterol therefore have complementary effects, treating two different components of asthma.

Timeline

Start
2012-02
Primary completion
2012-04
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 180 ug Inhaled
Subject Budesonide Small molecule 200 ug Inhaled
Subject Procaterol Other / unclassified 10 ug Inhaled