Relative Bioavailability of Olodaterol and Fluconazole
- Conditions
- HealthyPulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT01153724
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olodaterol BI 1744 - Olodaterol + Fluconazole BI 1744 - Olodaterol + Fluconazole Fluconazole -
- Primary Outcome Measures
Name Time Method Area Under Curve From 0 to 6 Hours at Steady State (AUC0-6,ss) Day 8 of period 1 and day 14 of period 2 AUC0-6,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=6 hours at steady state, where t is defined as the latest time-point where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of olodaterol. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Maximum Concentration at Steady State (Cmax,ss) Day 8 of period 1 and day 14 of period 2 Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide (a metabolite of olodaterol) in plasma at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
- Secondary Outcome Measures
Name Time Method Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss) Day 8 of period 1 and day 14 of period 2 tmax,ss represents the time from dosing to maximum concentration of olodaterol and olodaterol glucuronide in plasma at steady state.
Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss) Day 8 of period 1 and day 14 of period 2 fe0-24,ss represents the fraction of olodaterol eliminated in urine from time point 0 to 24 hours after administration at steady state.
Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss) Day 8 of period 1 and day 14 of period 2 Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide excreted in urine from 0 to time t=24 at steady state. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Area Under Curve From 0 to 12 Hours at Steady State (AUC0-12,ss) Day 8 of period 1 and day 14 of period 2 AUC0-12,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=12 at steady state, where t is defined as the latest timepoint where at least 2/3 of the subjects in both treatment periods reveal quantifiable plasma concentrations of the analyte. The geometric mean is actually the adjusted geometric mean. The geometric coefficient of variation (gCV) is the intra-individual gCV.
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG First administration of trial medication until 6 days after last administration of trial medication Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Assessment of Tolerability by the Investigator End of period 1 and end of period 2 The investigator assessed tolerability based on adverse events and the laboratory evaluation at the end-of-trial examination. The investigator classified the overall tolerability according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.
Trial Locations
- Locations (1)
1222.48.1 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany