A Clinical Study to Evaluate Z7200 (Budesonide/Formoterol) Pharmacokinetics Profile in Healthy Volunteers
Status:
Completed
Trial end date:
2015-02-01
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