Clinical Study to Evaluate Z7200 Pharmacokinetics Profile
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
Outcome
Mixed primary results
registry analysis (equivalence test); Treatment A vs Treatment B; p <0.001; Adjusted geometric means ratio 100.64 (90% CI 95.82 to 105.69); Mixed Models Analysis NCT02631941 ↗
registry analysis (equivalence test); Treatment A vs Treatment B; p = 1.00; Adjusted geometric means ratio 157.86 (90% CI 144.12 to 172.91); Mixed Models Analysis NCT02631941 ↗
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 |