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Clinical Trial to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin (MPI)

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.
 
ClinicalTrials.gov Identifier: NCT01857609
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Information provided by (Responsible Party):
Jae Yong Chung, Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE May 10, 2013
First Posted Date  ICMJE May 20, 2013
Last Update Posted Date May 20, 2013
Study Start Date  ICMJE August 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
AUC(area under the plasma concentration-time curve) [ Time Frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose ]
AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
AUG(total area under the serum concentration-time curve for glucose) [ Time Frame: predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test ]
AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin
Official Title  ICMJE The Cross-Over Study to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Korean Men.
Brief Summary This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics and pharmacodynamics of metformin in healthy Korean men.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Metformin
    Other Name: Diabex
  • Drug: Metformin and Pantoprazole
    Other Name: Diabex, Pantoloc
  • Drug: Metformin and Rabeprazole
    Other Name: Diabex, Pariet
Study Arms  ICMJE
  • Experimental: Metformin only
    metformin 750mg(D-1), metformin 500mg (D1)
    Intervention: Drug: Metformin
  • Experimental: Metformin and Pantoprazole
    pantoprazole 40mg(D-2)/ metformin 750mg + pantoprazole 40mg(D-1)/metformin 500mg + pantoprazole 40mg(D1)
    Intervention: Drug: Metformin and Pantoprazole
  • Experimental: Metformin and Rabeprazole
    rabeprazole 20mg(D-2)/metformin 750mg+rabeprazole 20mg(D-1)/metformin 500mg+rabeprazole 20mg(D1)
    Intervention: Drug: Metformin and Rabeprazole
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
Actual Enrollment  ICMJE
 (submitted: May 15, 2013)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy male subject aged 20 to 45 at screening
  • A body weight in the range of 50 kg (inclusive) - 100 kg (inclusive) with ideal body weight range of +- 25%
  • subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

  • subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
  • Subject judged not eligible for study participation by investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01857609
Other Study ID Numbers  ICMJE MPI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jae Yong Chung, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jae-Yong Chung, MD, PhD Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea
PRS Account Seoul National University Hospital
Verification Date May 2013

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