NCT04942652

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

An Open-label, Three-period, One-sequence Crossover Clinical Trial to Evaluate the Effects of Food or Proton Pump Inhibitor on the Pharmacokinetics of Itraconazole in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Evaluation criteria * Pharmacokinetic assessment with plasma concentrations of itraconazole and hydroxy-itraconazole * Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, and laboratory tests

Conditions

• Achlorhydria

Interventions

Type	Name	Description
DRUG	Itraconazole 200 mg	Itraconazole 100 mg capsule x 2
DRUG	Esomeprazole 40 mg	Esomeprazole 40 mg tablet x 1

Timeline

• Start date: 2021-07-13
• Primary completion: 2021-08-06
• Completion: 2021-08-24
• First posted: 2021-06-28
• Last updated: 2021-09-29

Locations

1 site across 1 country: South Korea