Study to investigate the relative bioavailability of BIBR 953 ZW after administration of a 150 mg BIBR 1048 HPMC (hydroxypropylmethylcellulose) capsule versus BIBR 953 ZW after administration of a 150 mg BIBR 1048 gelatine capsule, and to investigate the relative bioavailability of BIBR 953 ZW given as BIBR 1048 MS HPMC capsule with food versus without food.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
AUC0-∞ (area under the plasma concentration time curve from zero time extrapolated to infinity) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug
AUC0-tz (The area under the plasma concentration time curve from zero time to the time of the last quantifiable concentration) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug
Cmax (maximum measured concentration) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug
tmax (time from dosing to when the plasma concentration reaches Cmax after extravascular doses) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug
t½ (terminal half-life) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug
MRT (Total mean residence time) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug
CL/F (Total apparent clearance) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug
Vz/F (Apparent volume of distribution) of BIBR 953 ZW
Time frame: Before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours after administration of study drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.