The objective was to investigate the relative bioavailability of the fixed dose combination (FDC) tablet (80 mg telmisartan / 10 mg ramipril) after food intake in comparison to the bioavailability of the FDC tablet while fasting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
AUC0-∞ (area under the concentration-time curve of the analytes in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 96 hours after drug administration
AUC0-24 (area under the concentration-time curve of the analytes in plasma over one dosing interval from 0 to 24h)
Time frame: up to 96 hours after drug administration
Cmax (maximum measured concentration of the analytes in plasma)
Time frame: up to 96 hours after drug administration
AUC0-tz (area under the concentration-time curve of ramipril 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
tmax (time from dosing to the maximum concentration of the analytes 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 three analytes in plasma)
Time frame: up to 96 hours after drug administration
MRTpo (mean residence time of the analytes in the body after po administration)
Time frame: up to 96 hours after drug administration
CL/F (apparent clearance of the analytes in the plasma after extravascular administration)
Time frame: up to 96 hours after drug administration
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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 54 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 5 of each treatment period
Number of patients with clinically significant changes in Vital Signs (Blood Pressure, Pulse Rate)
Time frame: up to 54 days
Number of patients with clinically significant changes in laboratory tests
Time frame: up to 54 days
Number of patients with clinically significant changes in Electrocardiogram (ECG)
Time frame: up to 54 days
AUC0-tz (area under the concentration-time curve of ramiprilat and telmisartan 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