Pharmacokinetic Investigation of UDCA in Bile and Serum
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 12, 2007
CompletedFirst Posted
Study publicly available on registry
September 14, 2007
CompletedMay 7, 2019
May 1, 2019
September 12, 2007
May 3, 2019
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- PBC or healthy
You may not qualify if:
- pathology which does interfere with safety or PK of UDCA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beuers
Amsterdam, Netherlands
Related Publications (1)
Dilger K, Hohenester S, Winkler-Budenhofer U, Bastiaansen BA, Schaap FG, Rust C, Beuers U. Effect of ursodeoxycholic acid on bile acid profiles and intestinal detoxification machinery in primary biliary cirrhosis and health. J Hepatol. 2012 Jul;57(1):133-40. doi: 10.1016/j.jhep.2012.02.014. Epub 2012 Mar 10.
PMID: 22414767RESULT
Study Officials
- STUDY CHAIR
Ulrich Beuers, MD
University of Amsterdam
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2007
First Posted
September 14, 2007
Study Start
May 1, 2007
Last Updated
May 7, 2019
Record last verified: 2019-05