Healthy Clinical Trial - Pharmacokinetic Investigation of NCT00529009

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00529009
Other study ID #	URT-14/BIO
Secondary ID
Status	Completed
Phase	Phase 1
First received
Last updated
Start date	May 2007

Study information
Verified date	May 2019
Source	Dr. Falk Pharma GmbH
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

Description:

see protocol

Recruitment information / eligibility
Status	Completed
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	18 Years to 75 Years
Eligibility	Inclusion Criteria: - PBC or healthy Exclusion Criteria: - pathology which does interfere with safety or PK of UDCA

Study Design

Related Conditions & MeSH terms

Healthy

Intervention

Drug:
• UDCA

Locations
Country	Name	City	State
Netherlands	Beuers	Amsterdam

Sponsors *(1)*
Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Netherlands,

References & 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- — View Citation

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Pharmacokinetic Investigation of UDCA in Bile and Serum

Clinical Trial Details — Status: Completed

Administrative data

Study information