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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01857609

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Aug 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Metformin only

metformin 750mg(D-1), metformin 500mg (D1)

Drug: Metformin

Other Names:

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 Names:

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 Names:

Diabex, Pariet

Outcome Measures

Primary Outcome Measures

AUC(area under the plasma concentration-time curve) [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

AUG(total area under the serum concentration-time curve for glucose) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seoul,		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Jae-Yong Chung, MD, PhD, Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea