To assess the steady state pharmacokinetic profile of BIBR 953 ZW after administration of BIBR 1048 to male and female elderly subjects, to assess pharmacokinetic gender differences. To assess the effect of coadministration of Pantoprazole on the bioavailability of BIBR 953 ZW.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
BIBR 1048 MS capsule 150 mg
Pantoprazole tablet 40 mg
AUCτ,ss (area under the plasma concentration time curve during a dosing interval at steady state)
Time frame: Day 4 and 7
Cmax,ss (maximum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)
Time frame: Day 4 and 7
Aeτ,ss (amount of dose excreted in urine over one dosing interval at steady state)
Time frame: Day 4 and 7
feτ,ss (percent of dose excreted in urine over one dosing interval at steady state)
Time frame: Day 4 and 7
AUC0-tz,ss (area under the plasma concentration time curve (AUC) from zero time (pre dose) to the time of the last quantifiable concentration (tz))
Time frame: Day 4 and 7
Cmin,ss (minimum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)
Time frame: Day 4 and 7
tmax,ss (time from last dosing to the maximum concentration of the analyse in plasma at steady state over a uniform dosing interval τ)
Time frame: Day 4 and 7
t½,ss (terminal half-life, calculated from the terminal elimination rate constant)
Time frame: Day 4 and 7
CLR,ss (renal clearance at steady state following multiple dose administration)
Time frame: Day 4 and 7
MRTss (steady state mean residence time)
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Time frame: Day 4 and 7
CL/F,ss (apparent clearance of the analyse in plasma at steady state after extravascular multiple dose administration)
Time frame: Day 4 and 7
Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration)
Time frame: Day 4 and 7
Changes in activated partial thromboplastin time (aPTT)
Time frame: Day 4 and 7
Changes in ecarin clotting time (ECT)
Time frame: Day 4 and 7
Occurrence of Adverse Events
Time frame: up to 10 days