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Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems

NCT ID: NCT03000218

Last Updated: 2016-12-23

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Brief Summary

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A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid multiple administration

Detailed Description

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This study has a randomized, open-label, three-treatment, one-sequence, placebo-controlled, multiple drug administration design. The purpose of this study is as follows; To evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid administration

Conditions

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Overweight Abnormal Liver Function Tests

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UDCA 8 wks

Day 1 to 56: Ursodeoxycholic acid 300mg bid

Group Type EXPERIMENTAL

Ursodeoxycholic acid

Intervention Type DRUG

Ursodeoxycholic acid 300mg bid for 8 weeks

UDCA for 4wks/UDCA+metformin for 4wks

Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid

Group Type EXPERIMENTAL

Ursodeoxycholic acid

Intervention Type DRUG

Ursodeoxycholic acid 300mg bid for 8 weeks

Metformin

Intervention Type DRUG

Day 29 to 56: Metformin 500mg bid

Placebo

Day 1 to 56: Placebo bid

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Day 1 to 56: Placebo bid

Interventions

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Ursodeoxycholic acid

Ursodeoxycholic acid 300mg bid for 8 weeks

Intervention Type DRUG

Metformin

Day 29 to 56: Metformin 500mg bid

Intervention Type DRUG

Placebo

Day 1 to 56: Placebo bid

Intervention Type DRUG

Other Intervention Names

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Ursa tab Diabex tab

Eligibility Criteria

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Inclusion Criteria

* Healthy Subjects aged 18 - 50 years
* A body mass index (BMI) in the range of 25.0 kg/m2 - 30.0 kg/m2.
* A alanine aminotransferase (ALT) in the range of 40 - 200 IU/L
* 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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae Yong Chung, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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So Hee Jung

Role: CONTACT

Phone: +82-31-787-3968

Heecahn Lee

Role: CONTACT

Phone: +82-2-2072-4083

Facility Contacts

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Jae-Yong Chung, MD, PhD

Role: primary

Other Identifiers

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UDCA_overweight_LFTabnormal

Identifier Type: -

Identifier Source: org_study_id