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To Evaluate Pharmacokinetics and Safety of Two Different Formulation of Rebamipide in Healthy Volunteers

NCT04150172 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-11-04

No results posted yet for this study

Summary

This is a randomized, open label, multiple dose, crossover study to compare the safety and Pharmacokinetics (PKs) between two rebamipide formulations after multiple oral doses of "rebamipide SR 150 mg" and "rebamipide IR 100 mg" in healthy adult volunteers.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Rebamipide SR 150mg

Test drug

DRUG

Rebamipide IR 100mg

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
2019-04-22
Primary Completion
2019-05-01
Completion
2019-05-10

Countries

  • South Korea

Study Locations

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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 NCT04150172 on ClinicalTrials.gov