Phase 1
Completed N=35
Relative Bioavailability of Olodaterol and Fluconazole
Healthy · Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01153724 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss) — 19.659; 22.271 Picogram*hours/milliliter — p=0.0101
Summary
This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss) |
19.659; 22.271 | 0.0101 sig |
| PRIMARY Maximum Concentration at Steady State (Cmax,ss) |
5.336; 5.805; 4.211; 3.621 | 0.0009 sig |
| SECONDARY Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss) |
0.250; 0.250; 2.00; 2.03 | — |
| SECONDARY Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss) |
5.63; 6.45 | — |
| SECONDARY Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss) |
563.459; 647.004; 465.946; 347.030 | 0.1539 |
| SECONDARY Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss) |
33.389; 24.735 | 0.9646 |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG |
0; 0 | — |
| SECONDARY Assessment of Tolerability by the Investigator |
35; 30; 0; 3; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
Healthy male and female volunteers
Data sourced from ClinicalTrials.gov (NCT01153724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.