Overview

Clinical Study to Evaluate Z7200 Pharmacokinetics Profile

Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
The pharmacokinetics study aims to evaluate the safety of Z7200 (budesonide/formoterol) in comparison with Symbicort Turbohaler (budesonide/formoterol), assessing the bioequivalence of the two products. Namely the study will compare the total systemic bioavailability (as an indicator of safety), and it will compare the pulmonary bioavailability (as a possible surrogate indicator of efficacy). This study will be performed in healthy subjects.
Phase:
Phase 1
Details
Lead Sponsor:
Zambon SpA
Treatments:
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Charcoal
Formoterol Fumarate