drugset / Trial / NCT02143323

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

NCT02143323

Phase 1 Completed 32 enrolled Seoul National University Hospital
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-12
Primary completion
2014-08
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator AMOXICILIN Unknown
Comparator clavualanate Unknown

Indications

No indication recorded.