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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332890
First Posted: April 11, 2011
Last Update Posted: July 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yuhan Corporation
  Purpose
To evaluate drug-drug interaction

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
Intervention Model: Crossover Assignment
Masking: None (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:


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. ]
    Serum for each treatment period Experimental. AUCtau, Cmax will be estimated using non-compartmental analysis.


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)

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332890


Locations
Korea, Republic of
ASAN Medical Center, University of Ulsan
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
  More Information

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01332890     History of Changes
Other Study ID Numbers: YCD192
First Submitted: April 7, 2011
First Posted: April 11, 2011
Last Update Posted: July 10, 2014
Last Verified: July 2014

Keywords provided by Yuhan Corporation:
Drug interaction
revaprazan
Itopride HCI