Overweight Clinical Trial
Official title:
Clinical Study Evaluating Pharmacokinetics and Biomarkers After Ursodeoxycholic Acid (UDCA) Administration to Subjects Who Are Overweight and Have Liver Problems
A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid multiple administration
Status | Recruiting |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid | Day 1, 15, 29, 57 predose (0h), Day 29 1, 2, 3, 4h | No | |
Primary | Change from Baseline Low-density lipoprotein cholesterol at 8 weeks | Day 1, 29, 57, 71 predose (0h) | No |
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