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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Augmentin tab

• Registration Number: NCT02431832
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-01
• Primary Completion: 2015-10
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-28
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Augmentin tab	Augmentin tab	-

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	up to 35 days

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of