Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Elderly After UDCA Administration
- Registration Number
- NCT02789644
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
A clinical study to investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration
- Detailed Description
This study has a randomized, open-label, two-treatment, one-sequence, multiple drug administration design. The purpose of this study is as follows; To investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Healthy Subjects aged 70 - 84 years
- A body mass index (BMI) in the range of 18.5 kg/m2 - 29.9 kg/m2.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ursodeoxycholic acid 800mg Ursodeoxycholic Acid Day 1: Ursodeoxycholic acid 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid Ursodeoxycholic acid 400mg Ursodeoxycholic Acid Day 1: Ursodeoxycholic acid 400mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid predose and 2, 4, 5, 7, 9, 10, 12, 24h postdose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seoul, Korea, Republic of