Pharmacokinetic Investigation of UDCA in Bile and Serum

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00529009
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief 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.

Detailed Description

see protocol

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-09-12
• Study First Submitted QC: 2007-09-12
• Study First Posted: 2007-09-14
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• PBC or healthy

Exclusion Criteria

• pathology which does interfere with safety or PK of UDCA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Beuers; 🇳🇱 Amsterdam, Netherlands