Aged
Conditions
Keywords
Ursodeoxycholic acid, Metabolomics/biomarker, Pharmacokinetics
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
Interventions
DRUGUrsodeoxycholic Acid
Day 1: Ursodeoxycholic acid 400mg or 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 84 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid | predose and 2, 4, 5, 7, 9, 10, 12, 24h postdose |
Countries
South Korea
Contacts
Primary ContactJae-Yong Chung, M.D., Ph.D
Outcome results
None listed