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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers

NCT05832697

Healthy Subject

COMPLETED PHASE1

Compare the Pharmacokinetics and Safety of CKD-333 With Co-administration CKD-330 and D090 in Healthy Male Adults

NCT03849287

Hypertension Dyslipidemias

UNKNOWN PHASE1

Pharmacokinetic Investigation of UDCA in Bile and Serum

NCT00529009

Healthy

COMPLETED PHASE1

To Evaluate the Safety, Tolerability and to Compare the Pharmacokinetic Profile of ATX-101

NCT01462786

Healthy

COMPLETED PHASE1

A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-386(2) 80/20/10mg

NCT04987970

Hypertension and Dyslipidemia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aged

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ursodeoxycholic acid 400mg

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

Group Type EXPERIMENTAL

Ursodeoxycholic Acid

Intervention Type DRUG

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

Ursodeoxycholic acid 800mg

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

Group Type EXPERIMENTAL

Ursodeoxycholic Acid

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ursodeoxycholic Acid

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ursa tab.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

70 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes