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

Seoul National University Hospital24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

MetforminDRUG

Metformin and PantoprazoleDRUG

Metformin and RabeprazoleDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Bundang Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

AUC(area under the plasma concentration-time curve)

AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2

Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose

Secondary Outcomes

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)

Time frame: predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test

Data from ClinicalTrials.gov

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