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

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

Official Title
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The Cross-Over Study to Investigate the Effect of Proton Pump Inhibitor on the Pharmacokinetics and Pharmacodynamics of Metformin in Healthy Korean Men.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Metformin
* Drug: Metformin and Pantoprazole
* Drug: Metformin and Rabeprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin only<br>metformin 750mg(D-1), metformin 500mg (D1) | Drug: Metformin<br> <br> * Other names: Diabex;|
| Experimental: Metformin and Pantoprazole<br>pantoprazole 40mg(D-2)/ metformin 750mg + pantoprazole 40mg(D-1)/metformin 500mg + pantoprazole 40mg(D1) | Drug: Metformin and Pantoprazole<br> <br> * Other names: Diabex, Pantoloc;|
| Experimental: Metformin and Rabeprazole<br>rabeprazole 20mg(D-2)/metformin 750mg+rabeprazole 20mg(D-1)/metformin 500mg+rabeprazole 20mg(D1) | Drug: Metformin and Rabeprazole<br> <br> * Other names: Diabex, Pariet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(area under the plasma concentration-time curve) | AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2 | Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUG(total area under the serum concentration-time curve for glucose) | AUG (total area under the serum concentration-time curve for glucose) Gmax(maximum serum glucose concentration) | predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metformin, Proton pump inhibitor, Drug interaction