Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Sequence 2; Other: Sequence 1; Other: Sequence 5; Other: Sequence 3; Other: Sequence 4; Other: Sequence 6

• Registration Number: NCT01332890
• Lead Sponsor: Yuhan Corporation

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

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	Sequence 2	-
Sequence 1	Sequence 1	-
Sequence 5	Sequence 5	-
Sequence 3	Sequence 3	-
Sequence 4	Sequence 4	-
Sequence 6	Sequence 6	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	Blood sampling will be obtained on day 7 at each period.	Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis.

Trial Locations

Locations (1)

ASAN Medical Center, University of Ulsan; 🇰🇷 Seoul, Korea, Republic of