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

Healthy Clinical Trial

Official title:
A Clinical Study to Evaluate the Effect of Glutathion S-transferase Polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Amoxicillin/Clavulanate and Explore Biomarkers for Drug-induced Liver Injury (DILI)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02143323
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase Phase 1
Start date December 2013
Completion date September 2014
View Details
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