NCT04568772

Study to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers

A Randomized, Open-label, Three-period Crossover Clinical Trial to Evaluate the Influence of Tegoprazan on the Pharmacokinetics of Proguanil in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the influence of tegoprazan on the pharmacokinetics of proguanil in healthy volunteers.

Detailed description

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

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Atovaquone / Proguanil 250/100 mg	Atovaquone / Proguanil 250/100 mg tablet
DRUG	Tegoprazan 50 mg	Tegoprazan 50 mg tablet
DRUG	Esomeprazole 40 mg	Esomeprazole 40 mg tablet
DRUG	Vonoprazan 20 mg	Vonoprazan 20 mg tablet

Timeline

• Start date: 2020-11-25
• Primary completion: 2021-07-08
• Completion: 2021-08-03
• First posted: 2020-09-29
• Last updated: 2021-09-27

Locations

1 site across 1 country: South Korea