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

Seoul National University

Status and phase: Unknown; Phase 1

Conditions: Aged

Treatments: Drug: Ursodeoxycholic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02789644

UDCA_elderly

Details and patient eligibility

About

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

Full 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

Enrollment: 16 estimated patients

Sex: All

Ages: 70 to 84 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Ursodeoxycholic acid 400mg

Experimental group

Description:

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

Treatment:

Drug: Ursodeoxycholic Acid

Ursodeoxycholic acid 800mg

Experimental group

Description:

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

Treatment:

Drug: Ursodeoxycholic Acid