Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems

Seoul National University Hospital30 enrolled

Overview

A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid multiple administration

This study has a randomized, open-label, three-treatment, one-sequence, placebo-controlled, multiple drug administration design. The purpose of this study is as follows; To evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid administration

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overweight Abnormal Liver Function Tests

Interventions

Ursodeoxycholic acidDRUG

Ursodeoxycholic acid 300mg bid for 8 weeks

MetforminDRUG

Day 29 to 56: Metformin 500mg bid

PlaceboDRUG

Day 1 to 56: Placebo bid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Subjects aged 18 - 50 years * A body mass index (BMI) in the range of 25.0 kg/m2 - 30.0 kg/m2. * A alanine aminotransferase (ALT) in the range of 40 - 200 IU/L * Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations. Exclusion Criteria: * Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor * Subject judged not eligible for study participation by investigator