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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

September 12, 2007
May 5, 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
Not Provided

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: Open Label
Healthy
Drug: UDCA
Not Provided
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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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00529009
URT-14/BIO
No
Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
Not Provided
Study Chair: Ulrich Beuers, MD VU 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