Exploration of microRNA and Metabolomics Biomarkers Predicting Drug Induced Liver Injury in Elderly People

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Seoul National University

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Augmentin tab

Study type

Interventional

Funder types

Other

Identifiers

NCT02431832
DILI_Elderly

Details and patient eligibility

About

An open-label, one-sequence, multiple administration study for exploration of microRNA and metabolomics biomarkers to predict drug induced liver injury in healthy elderly Korean people.

Enrollment

17 patients

Sex

Male

Ages

65 to 84 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subjects, as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations were eligible to participate in the study. Subjects had to be 65 to 84 years of age.

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Augmentin tab
Experimental group
Treatment:
Drug: Augmentin tab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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