drugset / Trial / NCT02631941

Clinical Study to Evaluate Z7200 Pharmacokinetics Profile

NCT02631941

Phase 1 Completed 91 enrolled Zambon SpA
RandomizedCrossoverOpen-labelTreatment

Summary

Brief Summary: The primary objective was: * to assess the bioequivalence of a single dose (two inhalations) of the test product compared to the reference product, with and without charcoal blockade. The secondary objectives were: * to assess the pharmacokinetic profile of budesonide and formoterol in plasma after a single dose (two inhalations) of the test product and the reference product, with and without charcoal blockade. * to assess the safety and tolerability of the test product and the reference product, with and without charcoal blockade.

Timeline

Start
2016-01
Primary completion
2016-07
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 160 ug Inhaled
Subject Budesonide Small molecule 320 ug Inhaled
Subject Formoterol Other / unclassified 4.5 ug Inhaled
Subject Formoterol Other / unclassified 9 ug Inhaled

Indications