Pharmacokinetic Investigation of UDCA in Bile and Serum

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

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

Inclusion Criteria:

  • PBC or healthy

Exclusion Criteria:

  • pathology which does interfere with safety or PK of UDCA
  Contacts and Locations
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Please refer to this study by its identifier: NCT00529009

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

Responsible Party: Dr. Falk Pharma GmbH 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 processed this record on May 25, 2016