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

Study Overview
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Brief Summary
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To evaluate drug-drug interaction

Detailed Description
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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

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Sequence 1
* Other: Sequence 2
* Other: Sequence 3
* Other: Sequence 4
* Other: Sequence 5
* Other: Sequence 6


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br> | Other: Sequence 1<br>* Period1(A) Period2(B) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)<br>|
| Experimental: Sequence 2<br> | Other: Sequence 2<br>* Period1(C) Period2(A) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)<br>|
| Experimental: Sequence 3<br> | Other: Sequence 3<br>* Period1(B) Period2(C) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)<br>|
| Experimental: Sequence 4<br> | Other: Sequence 4<br>* Period1(C) Period2(B) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)<br>|
| Experimental: Sequence 5<br> | Other: Sequence 5<br>* Period1(B) Period2(A) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)<br>|
| Experimental: Sequence 6<br> | Other: Sequence 6<br>* Period1(A) Period2(C) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis. | Blood sampling will be obtained on day 7 at each period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug interaction, revaprazan, Itopride HCI