Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations based on sodium salt compared to the present commercial formulation (MicardisPlus®)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 72 hours after drug administration
Cmax (Maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
Amount of HCTZ excreted in urine over 48 hours (%Ae0-48h)
Time frame: up to 48 hours after drug administration
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time frame: up to 72 hours after drug administration
t1/2 (Terminal half-life of the analyte in plasma)
Time frame: up to 72 hours after drug administration
CLtot/F (Apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 72 hours after drug administration
MRTtot (Total mean residence time)
Time frame: up to 72 hours after drug administration
Vz/F (Apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: up to 72 hours after drug administration
Number of subjects with adverse events
Time frame: up to 32 days
Number of subjects with clinically significant findings in vital signs
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blood pressure, pulse rate
Time frame: up to 32 days
Number of subjects with clinically significant findings in 12 lead ECG
Time frame: up to 32 days
Investigator's assessment of tolerability on a 4-point scale
Time frame: up to 32 days