To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Low, medium or high dose
150mg
Area under the plasma drug concentration curve for BIBR 953 ZW from 0 to 12 hours (AUC0-12h)
Time frame: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Area under the plasma drug concentration time curve of BIBR 953 ZW within the interval from zero time to tf (last quantifiable plasma concentration) (AUC0-tf)
Time frame: before and 0.5, 1, 1.5, 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Maximum concentration of drug in plasma ( Cmax )
Time frame: before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: before and 0.5, 1, 1.5 2, 4, 6 h after dosing on day 1 and before and 0.5, 1, 1.5, 2, 4, 6, 8, 12 h after dosing on day 2 of each treatment
Changes from baseline in Pulse rate
Time frame: baseline up to 36 h after last administration
Changes from baseline in blood pressure (systolic and diastolic)
Time frame: baseline up to 36 h after last administration
Changes from baseline in ECG
Time frame: baseline up to 36 h after last administration
Changes from baseline in routine laboratory
Time frame: baseline up to 36 h after last administration
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Number of participants with adverse events
Time frame: up to 36 h after last administration
Changes in international normalized ratio (INR )
Time frame: before and 2 hours after treatment
Changes in activated prothrombin time (aPTT)
Time frame: before and 2 hours after treatment