The objective of the present study is to obtain information about the safety and tolerability of BIIF 1149 BS, to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Number of patients with adverse events
Time frame: up to 4 months
AUC (Area under the concentration-time curve of the analyte in plasma)
Time frame: up to 120 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 120 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 120 hours after drug administration
Ae (Amount of parent drug excreted into urine)
Time frame: up to 120 hours after drug administration
MRT (Mean residence time of the analyte in the body)
Time frame: up to 120 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 120 hours after drug administration
CL/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 120 hours after drug administration
Ae (amount of analyte excreted into Urine)
Time frame: up to 120 h after drug administration
CLren (renal clearance)
Time frame: up to 120 h after drug administration
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