Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A to Compare the Bioavailability of 2 Different Strengths of Kogenate FS (BAY14-2222)

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).

Inclusion Criteria:

• Males, age 18 to 65 years
• Subjects with Severe hemophilia A with a documented plasma FVIII level of <1%
• >/= 150 ED (exposure days) with FVIII concentrates(s) as supported by medical records

Exclusion Criteria:

• Evidence of current or past inhibitor antibody
• History of any congenital or acquired coagulation disorders other than hemophilia A
• Platelet count <75,000/mm3
• Abnormal renal function (serum creatinine >2 times the upper limit of the normal range)
• Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5x the upper limit of normal or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio (INR) >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices