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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Augmentin tab

Group Type EXPERIMENTAL

Augmentin tab

Intervention Type DRUG

Interventions

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Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

84 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes