A study to demonstrate the bioequivalence of telmisartan and HCTZ administered as fixed dose combination in comparison to the single unit formulations
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Total area under concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)
Time frame: Pre-dose up to day 54
Maximum concentration of the analytes in plasma (Cmax)
Time frame: Pre-dose up to day 54
Amount of HCTZ excreted in urine over 48 h (Ae(0-48))
Time frame: Pre-dose up to day 50
time to achieve maximum concentration of the analytes in plasma (tmax)
Time frame: Pre-dose up to day 54
Terminal elimination half life of the analytes in plasma (t1/2)
Time frame: Pre-dose up to day 54
Total clearance of the of the analytes after oral administration (CLtot/f)
Time frame: Pre-dose up to day 54
Total mean residence time of the analytes (MRTtot)
Time frame: Pre-dose up to day 54
Apparent volume of distribution of the analytes during the terminal phase (Vz/f)
Time frame: Pre-dose up to day 54
Number of patients with relevant changes in laboratory values
Time frame: Screening (day -14 to day 0) and day 72
Number of patients with relevant changes in vital signs (blood pressure, pulse rate)
Time frame: Up to day 72
Number of patients with Adverse events
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Time frame: Up to day 72
Number of patients with relevant changes in ECG
Time frame: Screening (day -14 to day 0) and day 72
Number of patients with relevant changes in physical examination
Time frame: Screening (day -14 to day 0) and day 72