Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery

Multicenter, Open-label-study to Assess PK Profile of a Single Oral Dose of 150 mg BIBR 1048 (Capsule) in Patients Shortly After Primary Elective Total Hip Replacement Surgery.

To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.

Inclusion Criteria:

• Patients scheduled to undergo a primary elective total hip replacement
• Male or female being 18 years or older (women of child bearing potential may not be included)
• Patients weighing at least 40 kg
• Written informed consent for participation

Exclusion Criteria:

• Bleeding disorders, e.g. history of intracranial, intraocular, gastrointestinal or pulmonary bleeding, known thrombocytopenia, history of haemorrhagic stroke
• Known renal disease
• Known liver disease, alcohol or drug misuse
• Known malignancy
• Treatment with another study drug in the past month