The objective of the present study was to obtain information about the safety and tolerability of BIIF 1149 BS after repeated dosing and to obtain preliminary pharmacokinetics data (steady state and accumulation factor)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Number of subjects with adverse events
Time frame: up to 55 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 8 days after last blood sample
Number of subjects with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: up to 8 days after last blood sample
Number of subjects with clinically significant changes in 12-lead Electrocardiogram (ECG)
Time frame: up to 8 days after last blood sample
Cmax (Maximum concentration of the analyte in plasma)
Time frame: up to 360 hours after last drug administration
Tmax (Time to maximum observed concentration of the analyte in plasma)
Time frame: up to 360 hours after last drug administration
AUC (Area under the concentration-time curve of the analyte in plasma)
Time frame: up to 360 hours after last drug administration
Ae (Urinary excretion of parent drug)
Time frame: up to 120 hours after last drug administration
Cmin,ss (Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: after 24 hours of drug administration on day 9
MRT (Mean residence time of the analyte in the body)
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Time frame: up to 360 hours after last drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 360 hours after last drug administration
Percent peak-trough fluctuation
Time frame: up to 360 hours after last drug administration
RA (AUC) Accumulation factor based on AUC-data
Time frame: up to 360 hours after last drug administration
RA (Ae) Accumulation factor based on Ae-data
Time frame: up to 120 hours after last drug administration
RA (Cmax) Accumulation factor based on Cmax -data
Time frame: up to 360 hours after drug administration on day 9
Cav (Average plasma concentration in a steady state interval)
Time frame: 24 hours after drug administration of day 9