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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02170935

Enrollment

Registered

2014-06-23

Start date

2002-04-30

Completion date

Unknown

Last updated

2014-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Brief summary

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.

Interventions

DRUGBIBR 1048 capsule

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
area under the plasma concentration time extrapolated to infinity (AUC0-infinity)	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
maximum plasma concentration (Cmax)	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
time to maximum plasma concentration (Tmax)	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
total clearance of drug from plasma	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
terminal elimination constant	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
time of last measureable BIBR 953 ZW plasma concentration (Tf)	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
area under the plasma concentration time curve until Tf (AUC0-Tf)	pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose

Secondary

Measure	Time frame
Occurrence of adverse events	up to 24 hours after drug administration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026