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Completed

NCT Number: NCT02431832

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

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.

Completed

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Key information

Conditions

Healthy

Age range

65 year–84 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmentin tab

Drug

Primary outcomes

  1. Area Under Curve (AUC)

    Time frame: up to 35 days

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
First posted
May 1, 2015
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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