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

Boehringer Ingelheim62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Thromboembolism

Interventions

BIBR 1048 capsuleDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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