Pharmacokinetic Investigation of UDCA in Bile and Serum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00529009
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : May 6, 2010
Information provided by:
Dr. Falk Pharma GmbH

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: UDCA Phase 1

Detailed Description:
see protocol

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : May 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • PBC or healthy

Exclusion Criteria:

  • pathology which does interfere with safety or PK of UDCA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00529009

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

Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT00529009     History of Changes
Other Study ID Numbers: URT-14/BIO
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: May 6, 2010
Last Verified: May 2010

Keywords provided by Dr. Falk Pharma GmbH:
PK analysis