drugset / Trial / NCT01153724

Relative Bioavailability of Olodaterol and Fluconazole

NCT01153724 ↗

Phase 1 Completed 35 enrolled Boehringer Ingelheim
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol

Timeline

Start
2010-05
Primary completion
2010-07
Completion
—

Outcome

Missed primary endpoint

registry Adjusted geometric mean ratio 113.29 (90% CI 105.893 to 121.197); ANOVA; note: P-value for ratio outside interval 0.8-1.25 NCT01153724 ↗

registry Adjusted geometric mean ratio 108.78 (90% CI 101.590 to 116.487); ANOVA; note: P-value for ratio outside interval 0.8-1.25 NCT01153724 ↗

registry Adjusted geometric mean 85.98 (90% CI 79.277 to 93.253); ANOVA; note: P-value for ratio outside interval 0.8-1.25 NCT01153724 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluconazole Small molecule 400 mg —
Subject Olodaterol Small molecule 10 ug Inhaled