The main objective of this trial is to investigate the absolute bioavailability of BI 1265162 following administration of oral solution and inhaled (with and without charcoal) via Respimat.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
oral solution
Solution for inhalation
concentrate for i.v. solution
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm)
Area under the concentration-time curve of BI 1265162 in plasma over the time interval from 0 extrapolated to infinity, dose-normalized to 1 µg BI 1265162, (AUC0-∞, norm). Time frame for treatment T1: Within 3 hours before and 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours following administration of the trial drug. Time frame for treatment T2 and T3: Within 3 hours before and 2, 5, 10, 15 and 40 minutes, 1, 2, 4, 8, 10, 12 and 24 hours following administration of the trial drug. Time frame for treatment R: Within 3 hours (h) before and 5, 30 and 59 minutes (min), 1 h 5 min, 1 h 10 min, 1 h 20 min, 1 h 40 min, 2, 2 h 30 min, 3, 3 h 30 min, 4, 5, 7, 9, 11, 13 and 24 hours following administration of the trial drug.
Time frame: Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Solution for inhalation