Pharmacokinetic Investigation of UDCA in Bile and Serum

This study has been completed.
Sponsor:
Information provided by:
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00529009
First received: September 12, 2007
Last updated: May 5, 2010
Last verified: May 2010
  Purpose

To assess the bile acid composition of cystic bile and serum pharmaco¬kinetics after a 3-week treatment with UDCA and to correlate pharmacokinetic parameters of UDCA in bile and serum during steady state.


Condition Intervention Phase
Healthy
Drug: UDCA
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Further study details as provided by Dr. Falk Pharma GmbH:

Study Start Date: May 2007
Detailed Description:

see protocol

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PBC or healthy

Exclusion Criteria:

  • pathology which does interfere with safety or PK of UDCA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529009

Locations
Netherlands
Beuers
Amsterdam, Netherlands
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Study Chair: Ulrich Beuers, MD VU University of Amsterdam
  More Information

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT00529009     History of Changes
Other Study ID Numbers: URT-14/BIO
Study First Received: September 12, 2007
Last Updated: May 5, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Falk Pharma GmbH:
PK analysis

ClinicalTrials.gov processed this record on July 26, 2014