A Clinical Study to Evaluate Z7200 (Budesonide/Formoterol) Pharmacokinetics Profile in Healthy Volunteers
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
- 2014-09
- Primary completion
- 2015-02
- Completion
- 2015-02
Outcome
Missed primary endpoint
registry analysis (equivalence test); Treatment A vs Treatment B; p <0.001; Adjusted geometric means ratio 138.87 (90% CI 129.09 to 149.39); Mixed Models Analysis NCT02237508 ↗
registry analysis (equivalence test); Treatment A vs Treatment B; p = 0.001; Adjusted geometric means ratio 119.73 (90% CI 109.40 to 131.03); Mixed Models Analysis NCT02237508 ↗
registry analysis (equivalence test); Treatment A vs Treatment B; p <0.001; Adjusted geometric means ratio 218.13 (90% CI 194.02 to 245.24); Mixed Models Analysis NCT02237508 ↗
registry analysis (equivalence test); Treatment A vs Treatment B; p <0.001; Adjusted geometric means ratio 126.17 (90% CI 115.93 to 137.32); Mixed Models Analysis NCT02237508 ↗
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 |