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

April 7, 2011
January 25, 2012
April 2011
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01332890 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • 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)
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01332890
YCD192
No
Principal Investigator: Kyun Seop Bae, MD, PhD, Asan Medical Center
Yuhan Corporation
Not Provided
Not Provided
Yuhan Corporation
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP