drugset / Trial / NCT02631941
Clinical Study to Evaluate Z7200 Pharmacokinetics Profile
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |