drugset / Trial / NCT02165033

Multiple-dose Pharmacokinetics Study of "SYN006 HFA MDI" Administered Orally to Healthy Volunteers

NCT02165033

Phase 1 Completed 16 enrolled Intech Biopharm Ltd.
NaSingle-groupOpen-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
2012-11
Primary completion
2013-01
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 720 ug Inhaled
Subject Procaterol Other / unclassified 40 ug Inhaled

Indications