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

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Metformin; Drug: Metformin and Rabeprazole; Drug: Metformin and Pantoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01857609

MPI

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Metformin only

Experimental group

Description:

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

Treatment:

Drug: Metformin

Metformin and Pantoprazole

Experimental group

Description:

pantoprazole 40mg(D-2)/ metformin 750mg + pantoprazole 40mg(D-1)/metformin 500mg + pantoprazole 40mg(D1)

Treatment:

Drug: Metformin and Pantoprazole

Metformin and Rabeprazole

Experimental group

Description:

rabeprazole 20mg(D-2)/metformin 750mg+rabeprazole 20mg(D-1)/metformin 500mg+rabeprazole 20mg(D1)

Treatment:

Drug: Metformin and Rabeprazole