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Evaluation of Metabolic Markers for the Prediction of DDI of Various CYP3A Substrates and Inhibitors

NCT02975037 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-10-27

No results posted yet for this study

Summary

Evaluation and validation of metabolic markers for the prediction of drug-drug interaction of various CYP3A4 substrates (sildenafil) and inhibitors (erythromycin/itraconazole) in healthy male subjects

Conditions

  • Healthy

Interventions

DRUG

Sildenafil

sildenafil 25 mg PO

DRUG

Clarithromycin

clarithromycin 250 mg PO

DRUG

Itraconazole

itraconazole 100 mg PO

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Joo-Youn Cho · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2017-03-04
Completion
2017-06-23

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 NCT02975037 on ClinicalTrials.gov