Pharmacokinetic Investigation of UDCA in Bile and Serum

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00529009

Enrollment

Unknown

Registered

2007-09-14

Start date

2007-05-31

Completion date

Unknown

Last updated

2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

PK analysis

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

Interventions

DRUGUDCA

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* PBC or healthy

Exclusion criteria

* pathology which does interfere with safety or PK of UDCA

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026