Study to demonstrate the bioequivalence (BE) of 40 mg telmisartan/ 2.5 mg ramipril fixed-dose combination (FDC) versus its monocomponents given concomitantly
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
AUC0-inf. (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 96 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 96 hours after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 96 hours after drug administration
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2)
Time frame: up to 96 hours after drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 96 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: up to 96 hours after drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 96 hours after drug administration
MRTpo (mean residence time of the analyte in the body after po administration)
Time frame: up to 96 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: up to 96 hours after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 96 hours after drug administration
Number of patients with adverse events
Time frame: up to 73 days
Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse Rate)
Time frame: up to 73 days
Number of patients with clinically relevant changes in laboratory tests
Time frame: up to 73 days
Number of patients with clinically relevant changes in 12-lead electrocardiogram
Time frame: up to 73 days