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

NCT04150146 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-11-04

No results posted yet for this study

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

DRUG

Rebamipide SR 150mg after high-fat meal

Test Drug

DRUG

Rebamipide SR 150mg under fasting condition

Reference Drug

Sponsors & Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-05
Primary Completion
2019-07-14
Completion
2019-07-24

Countries

  • South Korea

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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 NCT04150146 on ClinicalTrials.gov