NCT03863938

Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects

A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: Male
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers

Detailed description

Primary Outcome Measure: 1. AUClast and Cmax of tegaprazan 2. Gastric pH

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tegoprazan 50mg	K-CAB

Timeline

• Start date: 2019-03-27
• Primary completion: 2019-04-26
• Completion: 2019-06-25
• First posted: 2019-03-05
• Last updated: 2019-08-22

Locations

1 site across 1 country: South Korea