To investigate the bioavailability of dabigatran with and without concomitant administration of digoxin and the bioavailability of digoxin with and without concomitant administration of dabigatran etexilate
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Time frame: Up to 72 hours after drug administration on day 4
Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)
Time frame: 2 hours before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after drug administration on day 4
Area under the concentration-time curve of the analyte in plasma from the time point 0 after the last dose at steady state to the last quantifiable analyte plasma concentration within the uniform dosing interval τ (AUC0-tz,ss)
Time frame: Up to 72 hours after drug administration on day 4
Time of last measurable concentration of the analyte in plasma within the dosing interval τ at steady state (tz,ss)
Time frame: Up to 72 hours after drug administration on day 4
Time from last dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)
Time frame: Up to 72 hours after drug administration on day 4
Apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration (CL/Fss)
Time frame: Up to 72 hours after drug administration on day 4
Renal clearance of the analyte at steady state determined over the dosing interval τ (CLR,ss)
Time frame: Up to 24 hours after drug administration on day 4
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: Up to 72 hours after drug administration on day 4
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Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ ( tmin,ss)
Time frame: Up to 72 hours after drug administration on day 4
Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time frame: 2 hours before drug administration on day 4
Mean residence time of the analyte in the body at steady state after p.o. administration (MRTp.o.,ss)
Time frame: Up to 72 hours after drug administration on day 4
Fraction of parent drug eliminated in urine at steady state over a uniform dosing interval τ (feτ,ss)
Time frame: Up to 24 hours after drug administration on day 4
Assessment of tolerability by investigator on a four point scale (good, satisfactory, not satisfactory, bad)
Time frame: Day 76
Apparent volume of distribution during the terminal phase λz at steady state following an extravascular administration (Vz/Fss)
Time frame: Up to day 7
Amount of analyte that was eliminated in urine at steady state over an uniform dosing interval τ (Aeτ,ss)
Time frame: Up to 24 hours after drug administration on day 4
Area under the effect ratio curve (AUERτ,ss) for activated prothrombin time (aPTT) and ecarin clotting time (ECT)
Time frame: Up to 72 hours after drug administration on day 4
Prolongation at trough (ERpre,ss) for aPTT
Time frame: Up to 72 hours after drug administration on day 4
Change from baseline in physical examination
Time frame: Baseline, day 76
Change from baseline in vital signs (blood pressure, pulse rate)
Time frame: Baseline, day 76
Change from baseline in 12-lead electrocardiogram
Time frame: Baseline, day 76
Change from baseline in clinical laboratory tests
Time frame: Baseline, day 76
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to day 76
Maximum effect ratio at steady state (ERmax,ss) for aPTT and ECT
Time frame: Up to 72 hours after drug administration on day 4
Prolongation at trough (ERpre,ss) for ECT
Time frame: Up to 72 hours after drug administration on day 4