Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Elderly After UDCA Administration

Seoul National University Hospital16 enrolled

Overview

A clinical study to investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aged

Interventions

Ursodeoxycholic AcidDRUG

Day 1: Ursodeoxycholic acid 400mg or 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid

Eligibility

Sex: ALLMin age: 70 YearsMax age: 84 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid

Time frame: predose and 2, 4, 5, 7, 9, 10, 12, 24h postdose

Central Contacts

Jae-Yong Chung, M.D., Ph.D

CONTACT

+82-031-787-3955

Data from ClinicalTrials.gov

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