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Pharmacokinetic Investigation of UDCA in Bile and Serum

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00529009
First Posted: September 14, 2007
Last Update Posted: May 6, 2010
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.
Information provided by:
Dr. Falk Pharma GmbH
September 12, 2007
September 14, 2007
May 6, 2010
May 2007
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Complete list of historical versions of study NCT00529009 on ClinicalTrials.gov Archive Site
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Pharmacokinetic Investigation of UDCA in Bile and Serum
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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.
see protocol
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Healthy
Drug: UDCA
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • PBC or healthy

Exclusion Criteria:

  • pathology which does interfere with safety or PK of UDCA
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00529009
URT-14/BIO
No
Not Provided
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Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
Not Provided
Study Chair: Ulrich Beuers, MD University of Amsterdam
Dr. Falk Pharma GmbH
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP