A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects

Yuhan Corporation1 site in 1 country30 target enrollmentApril 2011

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Yuhan Corporation
Enrollment: 30
Locations: 1
Primary Endpoint: Pharmacokinetics
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate drug-drug interaction

Detailed Description

The main objective is to evaluate the pharmacokinetic profile of the 50mg Revaprazan plus 50mg Itopride compared to 50mg Revaprazan or 50mg Itopride alone in healthy Korean subjects

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

August 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Yuhan Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males aged 20 to 50 years old, with a body mass index (BMI) between 19 and 27 kg/m2
•Acceptable medical history, physical exam,laboratory tests and EKG, during screening
•Eligible for blood sampling during study period
•Provision of signed written informed consent

Exclusion Criteria

•History of any clinically significant disease
•History of drug/chemical/alcohol abuse
•Clinically significant illness or within 30days before the first dose
•Use of medication known to chronically alter drug absorption or elimination processes within 30days before the first dose of investigational product
•Use of prescribed medication during the 14 days before administration of the first dose of investigational product
•Use of any non-prescribed medication during the 7 days before administration of the first dose of investigational product - Use of any oriental medication medication during the 30 days before administration of the first dose of investigational product
•Participated in a clinical study involving administration of an investigational drug (new chemical entity) or a marketed drug within past 90 days
•Consuming more than 21 units of alcohol per week
•Smoking more than 20 cigarettes per day or consuming more than 5 cups of caffeinated beverages.