NCT04150146

To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers

A Randomized, Open Label, Single Dose, Crossover Study to Evaluate the Food Effect on the Pharmacokinetics of "Rebamipide Sustained Release (SR) 150mg" in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open label, single dose, crossover study to evaluate the food effect on the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult volunteers.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Rebamipide SR 150mg after high-fat meal	Test Drug
DRUG	Rebamipide SR 150mg under fasting condition	Reference Drug

Timeline

• Start date: 2019-07-05
• Primary completion: 2019-07-14
• Completion: 2019-07-24
• First posted: 2019-11-04
• Last updated: 2019-11-04

Locations

1 site across 1 country: South Korea