The main objective was to investigate the effect of concurrent dosing of 10 mg ramipril and 80 mg telmisartan on the multiple-dose pharmacokinetics of telmisartan and ramipril. Therefore the relative bioavailability of telmisartan and ramipril given in combination was determined in comparison with either telmisartan or ramipril given alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
AUCτ,ss (area under the concentration-time curve in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 72 hours after last drug administration of each treatment
Cmax,ss (maximum measured concentration in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 72 hours after last drug administration of each treatment
Concentration of the analytes in plasma
Time frame: 2, 4, and 12 hours after administration of the first dose of each treatment on day 1
pre-dose concentration of the analytes in plasma immediately before the administration of the next dose
Time frame: pre-dose up to day 5 of each treatment
tmax,ss (time from last dosing to the maximum concentration of the analytes in plasma at steady state)
Time frame: up to 72 hours after last drug administration of each treatment
Cmin,ss (minimum concentration of the analytes in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 72 hours after last drug administration of each treatment
Cpre,ss (pre-dose concentration of the analytes in plasma immediately before the administration of the next dose at steady state)
Time frame: pre-dose up to day 5 of each treatment
Cavg (average concentration of the analytes in plasma at steady state)
Time frame: up to 72 hours after last drug administration of each treatment
λz,ss (terminal rate constant in plasma at steady state)
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Time frame: up to 72 hours after last drug administration of each treatment
t1/2, ss (terminal half-life of the analyte in plasma at steady state)
Time frame: up to 72 hours after last drug administration of each treatment
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration)
Time frame: up to 72 hours after last drug administration of each treatment
CL/F,ss (apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration)
Time frame: up to 72 hours after last drug administration of each treatment
Vz/F,ss (apparent volume of distribution of the analyte in plasma at steady state after extravascular multiple dose administration)
Time frame: up to 72 hours after last drug administration of each treatment
PTF (Peak-Trough Fluctuation)
Time frame: up to 72 hours after last drug administration of each treatment
AUC0-tz,ss (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 72 hours after last drug administration of each treatment
Number of patients with adverse events
Time frame: up to day 76
Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse rate)
Time frame: up to day 76
Number of patients with clinically relevant changes in 12-lead electrocardiogram
Time frame: up to day 76
Number of patients with clinically relevant changes in laboratory tests
Time frame: up to day 76
Assessment of tolerability by the investigator on a 4-point scale
Time frame: Day 8 of each treatment