Pharmacokinetic Investigation of UDCA in Bile and Serum

NCT ID: NCT00529009

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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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.

Detailed Description

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see protocol

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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UDCA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* PBC or healthy

Exclusion Criteria

* pathology which does interfere with safety or PK of UDCA
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Falk Pharma GmbH

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ulrich Beuers, MD

Role: STUDY_CHAIR

University of Amsterdam

Locations

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Beuers

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 22414767 (View on PubMed)

Other Identifiers

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URT-14/BIO

Identifier Type: -

Identifier Source: org_study_id

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