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Assessment of Change in CYP3A Activity by Route of Administration Using Metabolic Markers in Healthy Male Volunteers

NCT03366974 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-10-27

No results posted yet for this study

Summary

The study objective is to evaluate and validate of endogenous markers for the assessment of change in CYP3A activity by route of administration in Korean healthy subjects using metabolomics. In addition, we aim to screen novel endogenous marker, which could determine the total or intestinal CYP activity.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Midazolam

Midazolam 5 mg PO, Midazolam 1 mg IV

DRUG

Clarithromycin

Clarithromycin 500 mg bid

DIETARY_SUPPLEMENT

Grapefruit juice

Grapefruit juice 500 mL

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Joo-Youn Cho · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-28
Primary Completion
2018-02-13
Completion
2018-12-12

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03366974 on ClinicalTrials.gov