Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120 soft gelatine capsule with food effect (BA) in healthy subjects respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
150 mg of BIBF 1120 ES soft gelatine capsules
AUC0-∞ (area under the concentration-time curve in plasma over time from zero time extrapolated to infinity)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Cmax (maximum observed concentration in plasma)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
tmax (time from dosing to reach Cmax)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
t1/2 (terminal half-life in plasma)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
MRTpo (mean residence time in the body)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
CL/F (apparent clearance in plasma following extravascular administration)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Vz/F (apparent volume of distribution during the terminal phase following extravascular administration)
Time frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug
Incidence and intensity of adverse events
Time frame: up to 14 days
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Changes from baseline in vital signs (systolic and diastolic blood pressure, Pulse rate)
Time frame: up to 14 days
Changes from baseline in laboratory tests
Time frame: up to 14 days
Assessment of global tolerability on a 4-point scale
Time frame: Day 3 of each treatment period
Changes from baseline in 12-lead electrocardiogram
Time frame: up to 14 days