Relative Bioavailability of of Olodaterol and Ketoconazole

实验性的：BI 1744 10 mcg

solution for oral inhalation

药品：BI 1744

10 mcg solution for oral inhalation

药品：Ketoconazole

400 mg tablet

实验性的：Ketoconazole 400 mg

tablet

药品：BI 1744

10 mcg solution for oral inhalation

药品：Ketoconazole

400 mg tablet

Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)

AUC0-1,ss represents the area under the concentration curve of olodaterol in plasma from 0 to time t=1 hour 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)

Cmax,ss represents the maximum concentration of olodaterol and olodaterol glucuronide 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.

Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)

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)

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)

Ae0-24,ss represents the amount of olodaterol and olodaterol glucuronide that is eliminated in urine from the time 0 to 24h after administration 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 8 Hours at Steady State (AUC0-8,ss)

AUC0-8,ss represents the area under the concentration curve of olodaterol glucuronide in plasma from 0 to time t=8 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 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

Clinical relevant abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as treatment-induced Adverse Events.

Assessment of Tolerability by the Investigator

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'.