Study to investigate the steady state pharmacokinetics of 80 mg telmisartan alone and in combination with repeated doses of 10 mg amlodipine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Area under the concentration-time curve of telmisartan in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Time frame: up to 15 days after first administration of study drug
Maximum measured concentration of telmisartan in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: up to 15 days after first administration of study drug
AUCτ,ss for amlodipine
Time frame: up to 15 days after first administration of study drug
Cmax,ss for amlodipine
Time frame: up to 15 days after first administration of study drug
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 12 hours after first administration of study drug
Time from dosing to maximum measured concentration on plasma (tmax)
Time frame: up to 12 hours after first administration of study drug
Area under the plasma concentration-time curve over a uniform dosing interval τ after administration of the first dose; corresponds to AUC0-24h (AUCτ,1)
Time frame: up to 12 hours after first administration of study drug
Pre-dose concentration of the analyte in plasma immediately before the administration of the next dose N (Cpre,N)
Time frame: pre-dose on days 2-9
Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: up to 144 hours after last administration of study drug
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Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: up to 144 hours after last administration of study drug
Terminal rate constant in plasma at steady state (λz,ss)
Time frame: up to 144 hours after last administration of study drug
Terminal half-life of the analyte in plasma at steady state (t1/2, ss)
Time frame: up to 144 hours after last administration of study drug
Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)
Time frame: up to 144 hours after last administration of study drug
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Time frame: up to 144 hours after last administration of study drug
Apparent volume of distribution of the analyte in plasma at steady state after extravascular multiple dose administration (Vz/F,ss)
Time frame: up to 144 hours after last administration of study drug
Accumulation ratio of the analyte in plasma based on AUC over a uniform dosing interval after the first and last doses (RA, AUC)
Time frame: up to 15 days after first administration of study drug
Accumulation ratio of the analyte in plasma based on Cmax over a uniform dosing interval after the last and first doses (RA,Cmax)
Time frame: up to 15 days after first administration of study drug
Number of subjects with adverse events
Time frame: up to 80 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: within 14 days after last trial procedure