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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
  Purpose

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


Condition Intervention Phase
Healthy
 Other: Sequence 1
Other: Sequence 2
Other: Sequence 3
Other: Sequence 4
Other: Sequence 5
Other: Sequence 6
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: April 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 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)
Experimental: Sequence 2 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)
Experimental: Sequence 3 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)
Experimental: Sequence 4 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)
Experimental: Sequence 5 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)
Experimental: Sequence 6 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)

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332890

Locations
Korea, Republic of
Yuhan Corporation
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
  More Information

No publications provided

Responsible Party: Principal Investigator: Kyun Seop Bae, MD, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01332890     History of Changes
Other Study ID Numbers: YCD192
Study First Received: April 7, 2011
Last Updated: January 25, 2012
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Yuhan Corporation:
Drug interaction
revaprazan
Itopride HCI

ClinicalTrials.gov processed this record on May 19, 2013