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

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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

Brief Summary:
This study aims to investigate the effect of proton pump inhibitor on the pharmacokinetics and pharmacodynamics of metformin in healthy Korean men.

Condition or disease Intervention/treatment Phase
Healthy Drug: Metformin Drug: Metformin and Pantoprazole Drug: Metformin and Rabeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Cross-Over Study to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Korean Men.
Study Start Date : August 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Experimental: Metformin only
metformin 750mg(D-1), metformin 500mg (D1)
Drug: Metformin
Other Name: Diabex

Experimental: Metformin and Pantoprazole
pantoprazole 40mg(D-2)/ metformin 750mg + pantoprazole 40mg(D-1)/metformin 500mg + pantoprazole 40mg(D1)
Drug: Metformin and Pantoprazole
Other Name: Diabex, Pantoloc

Experimental: Metformin and Rabeprazole
rabeprazole 20mg(D-2)/metformin 750mg+rabeprazole 20mg(D-1)/metformin 500mg+rabeprazole 20mg(D1)
Drug: Metformin and Rabeprazole
Other Name: Diabex, Pariet




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT01857609


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seoul,, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jae-Yong Chung, MD, PhD Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea
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Responsible Party: Jae Yong Chung, Assistant Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01857609    
Other Study ID Numbers: MPI
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: May 20, 2013
Last Verified: May 2013
Keywords provided by Jae Yong Chung, Seoul National University Bundang Hospital:
Metformin
Proton pump inhibitor
Drug interaction
Additional relevant MeSH terms:
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Metformin
Rabeprazole
Pantoprazole
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action