Pharmacokinetic Investigation of UDCA in Bile and Serum

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beuers

Amsterdam, Netherlands

About this study

see protocol

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

PBC or healthy

Exclusion criteria

pathology which does interfere with safety or PK of UDCA

Treatment and study plan

UDCA

Drug

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Important dates

Study start: 2007
First posted: Sep 14, 2007
Registry last updated: May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed