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

This study has been completed.

Sponsor:

Information provided by:

Yuhan Corporation

ClinicalTrials.gov Identifier:

NCT01332890

First received: April 7, 2011

Last updated: January 25, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 7, 2011
Last Updated Date	January 25, 2012
Start Date ^ICMJE	April 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 8, 2011)	Pharmacokinetics [ Time Frame: Blood sampling will be obtained on day 7 at each period. ] [ Designated as safety issue: Yes ] Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01332890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
Official Title ^ICMJE	A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
Brief Summary	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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Other: 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) 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) 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) 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) 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) 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)
Study Arm (s)	Experimental: Sequence 1 Intervention: Other: Sequence 1 Experimental: Sequence 2 Intervention: Other: Sequence 2 Experimental: Sequence 3 Intervention: Other: Sequence 3 Experimental: Sequence 4 Intervention: Other: Sequence 4 Experimental: Sequence 5 Intervention: Other: Sequence 5 Experimental: Sequence 6 Intervention: Other: Sequence 6
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	30
Completion Date	August 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	20 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01332890
Other Study ID Numbers ^ICMJE	YCD192
Has Data Monitoring Committee	No
Responsible Party	Principal Investigator: Kyun Seop Bae, MD, PhD, Asan Medical Center
Study Sponsor ^ICMJE	Yuhan Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yuhan Corporation
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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