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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01857609

Acronym

MPI

Enrollment

Registered

2013-05-20

Start date

2012-08-31

Completion date

2012-12-31

Last updated

2013-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Metformin, Proton pump inhibitor, Drug interaction

Brief summary

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

Interventions

DRUGMetformin

DRUGMetformin and Pantoprazole

DRUGMetformin and Rabeprazole

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026