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

June 20, 2014 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BIBR 1048 capsule
Drug: BIBR 1048 capsule

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events
Time Frame: up to 24 hours after drug administration
up to 24 hours after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (ACTUAL)

June 1, 2002

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (ESTIMATE)

June 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2014

Last Update Submitted That Met QC Criteria

June 20, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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