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A Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)

NCT02143323 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-12-23

No results posted yet for this study

Summary

This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;

* To evaluate the change of liver function according to glutathione s-transferase (GST) genotype after the multiple administration of amoxicillin/clavulanate.
* To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.

Conditions

  • Healthy

Interventions

DRUG

Augmentin tablet

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • In-Jin Jang, MD, PhD · Seoul National University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02143323 on ClinicalTrials.gov