This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)
50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)
Unnamed facility
Sofia, Bulgaria
Maximum plasma concentration (Cmax) of BAY14-2222
Time frame: Up to 48 hours
Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222
Time frame: Up to 48 hours
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