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

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)

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17 participants in 1 patient group

Augmentin tab

Experimental group

Treatment:

Drug: Augmentin tab