Group 1: To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T40/H12.5 and T80/H12.5) Group 2: To investigate safety, tolerability and pharmacokinetics of Telmisartan + HCTZ (T80/H12.5 x 7 days)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Number of patients with clinically relevant findings in physical examination
Time frame: up to 10 days after last drug administration
Number of patients with clinically relevant findings in vital signs
blood pressure, pulse rate, body temperature
Time frame: up to 10 days after last drug administration
Number of patients with clinically relevant findings in 12-lead ECG
Time frame: up to 10 days after last drug administration
Number of patients with clinically relevant findings in clinical laboratory tests
Time frame: up to 10 days after last drug administration
Number of patients with adverse events
Time frame: up to 10 days after last drug administration
Global assessment of tolerability by the investigator
verbal rating scale
Time frame: up to 10 days after last drug administration
Maximum concentration of the analytes in plasma (Cmax)
Time frame: Up to 96 hours after drug administration
Area under the concentration time curve of the analytes in plasma (AUC)
Time frame: Up to 96 hours after drug administration
Time from dosing to maximum concentration of the analytes in plasma (tmax)
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.
Terminal rate constant of the analytes in plasma (λz)
Time frame: Up to 96 hours after drug administration
Terminal half-life of the analytes in plasma (t1/2)
Time frame: Up to 96 hours after drug administration
Mean residence time of the analytes in the body after po administration (MRTpo)
Time frame: Up to 96 hours after drug administration
Apparent clearance of the analytes in the plasma after extravascular administration (CL/F)
Time frame: Up to 96 hours after drug administration
Apparent volume of distribution of the analytes in plasma during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: Up to 96 hours after drug administration
Amount of HCTZ that is eliminated in urine from the time interval t1 to t2 (Aet1-t2)
Time frame: Up to 48 hours after drug administration
Fraction of HCTZ excreted unchanged in urine from time point t1 to t2 (fet1-t2)
Time frame: Up to 48 hours after drug administration
Renal clearance of HCTZ in plasma from the time point t1 until the time point t2 (CLR, t1-t2)
Time frame: Up to 48 hours after drug administration
Minimum measured concentration of the analytes in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: Up to 96 hours after drug administration
Average concentration of the analytes in plasma at steady state (Cavg)
Time frame: Up to 96 hours after drug administration
Accumulation ratio of the analytes in plasma after multiple dose administration over a uniform dosing interval τ (RA)
Time frame: Up to 96 hours after drug administration