CompletedNCT00529009Updated May 7, 2019

Pharmacokinetic Investigation of UDCA in Bile and Serum

A Phase 1 interventional study of UDCA in Healthy, sponsored by Dr. Falk Pharma GmbH. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-07.

Sponsored by Dr. Falk Pharma GmbH · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Read the detailed description

see protocol

Conditions studied

Healthy

Keywords

PK analysis

In context

Lead sponsor

Dr. Falk Pharma GmbH is the lead sponsor of 38 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

PBC or healthy

Exclusion criteria

Exclusion Criteria:

pathology which does interfere with safety or PK of UDCA

Study design

Phase: Phase 1
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)

Interventions

DrugUDCA

Study locations

1 site

Beuers
Amsterdam, Netherlands

References and documents

Publications

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. Erratum In: J Hepatol. 2014 Mar;60(3):684. PubMed 22414767 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00529009
Lead sponsor: Dr. Falk Pharma GmbH
First posted: Sep 14, 2007
Start date: May 2007
Last update: May 7, 2019

Study contacts

Ulrich Beuers, MD

study chair · University of Amsterdam

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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