The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Number of subjects with adverse events
Time frame: up to 3 months
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 8 days after last drug administration
Change in impedance cardiography
Time frame: up to 30 minutes after drug administration
Change in cutaneous microcirculation
Time frame: up to 30 minutes after drug administration
Change in airway resistance (Raw) after methacholine challenge
Time frame: up to 30 minutes after drug administration
Change in specific conductance (sGaw) after methacholine challenge
Time frame: up to 30 minutes after drug administration
AUC (Area under the concentration-time curve of the analyte in plasma)
Time frame: up to 168 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 168 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 168 hours after drug administration
Ae (Amount of analyte that is eliminated in urine)
Time frame: up to 48 hours after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MRT (Mean residence time of the analyte in the body)
Time frame: up to 168 hours after drug administration
t½ (Terminal half-life of the analyte in plasma)
Time frame: up to 168 hours after drug administration
CL/F(Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 168 hours after drug administration