Pharmacokinetic Investigation of UDCA in Bile and Serum

This study is ongoing, but not recruiting participants.

Sponsored by:	Dr. Falk Pharma GmbH
Information provided by:	Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:	NCT00529009

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: UDCA	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Parallel Assignment

Further study details as provided by Dr. Falk Pharma GmbH:

Study Start Date:

May 2007

Detailed Description:

see protocol

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

PBC or healthy

Exclusion Criteria:

pathology which does interfere with safety or PK of UDCA

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529009

Locations

Netherlands
Beuers
Amsterdam, Netherlands

Sponsors and Collaborators

Dr. Falk Pharma GmbH

Investigators

Study Chair:

Ulrich Beuers, MD

University of Amsterdam

More Information

Responsible Party:	( Dr. Falk Pharma GmbH )
Study ID Numbers:	URT-14/BIO
Study First Received:	September 12, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00529009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dr. Falk Pharma GmbH:

PK analysis

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 15, 2009