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

NCT ID: NCT01332890

Last Updated: 2014-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-08-31

Brief Summary

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To evaluate drug-drug interaction

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

Group Type EXPERIMENTAL

Sequence 1

Intervention Type OTHER

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)

Sequence 2

Group Type EXPERIMENTAL

Sequence 2

Intervention Type OTHER

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)

Sequence 3

Group Type EXPERIMENTAL

Sequence 3

Intervention Type OTHER

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)

Sequence 4

Group Type EXPERIMENTAL

Sequence 4

Intervention Type OTHER

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)

Sequence 5

Group Type EXPERIMENTAL

Sequence 5

Intervention Type OTHER

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)

Sequence 6

Group Type EXPERIMENTAL

Sequence 6

Intervention Type OTHER

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)

Interventions

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Sequence 1

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)

Intervention Type OTHER

Sequence 2

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)

Intervention Type OTHER

Sequence 3

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)

Intervention Type OTHER

Sequence 4

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)

Intervention Type OTHER

Sequence 5

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)

Intervention Type OTHER

Sequence 6

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)

Intervention Type OTHER

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ASAN Medical Center, University of Ulsan

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YCD192

Identifier Type: -

Identifier Source: org_study_id

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