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Study to Evaluate Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers

NCT04942652 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-09-29

No results posted yet for this study

Summary

The aim of this study is to evaluate the effects of food or proton pump inhibitor on the pharmacokinetics of itraconazole in healthy volunteers.

Conditions

  • Achlorhydria

Interventions

DRUG

Itraconazole 200 mg

Itraconazole 100 mg capsule x 2

DRUG

Esomeprazole 40 mg

Esomeprazole 40 mg tablet x 1

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • SeungHwan Lee, MD, PhD · Seoul National University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2021-08-06
Completion
2021-08-24

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 NCT04942652 on ClinicalTrials.gov