The main objective of the current trial is to investigate safety, tolerability and pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Film-coated tablet
Film-coated tablet
Film-coated tablet
Boehringer Ingelheim Investigational Site
Berlin, Germany
Boehringer Ingelheim Investigational Site
Frankfurt, Germany
Boehringer Ingelheim Investigational Site
Gauting, Germany
Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
Number (%) of Patients With Drug-related Adverse Events (AEs)
Number (%) of patients with drug-related adverse events (AEs)
Time frame: AE's occuring upto end of treatment + 3 days follow up (Up to 31 days)
Cmax,ss
Cmax,ss (maximum measured concentration of BI 113608 in plasma at steady state over a uniform dosing interval tau)
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
AUC Tau,ss
AUC tau,ss (area under the concentration-time curve of the BI 113608 in plasma at steady state over a uniform dosing interval tau)
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
Tmax,ss
Tmax,ss (time from last dosing to maximum concentration of the BI 113608 in plasma at steady state)
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
T1/2,ss
T1/2,ss (terminal half life of the BI 113608 in plasma at steady state)
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Film-coated tablet
Film-coated tablet
Film-coated tablet
Boehringer Ingelheim Investigational Site
Lübeck, Germany
Boehringer Ingelheim Investigational Site
Mannheim, Germany
R(A,Cmax)
R(A,Cmax) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after first dose)
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
R(A,AUC)
R(A,AUC) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after first dose)
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration