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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Metformin (Drug); Metformin and Pantoprazole (Drug); Metformin and Rabeprazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jae-Yong Chung, MD, PhD, Principal Investigator, Affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: AUC(area under the plasma concentration-time curve)

Secondary outcome: AUG(total area under the serum concentration-time curve for glucose)

Eligibility

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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 and Contacts

Seoul National University Bundang Hospital, Seoul,, Korea, Republic of
Additional Information

Starting date: August 2012
Last updated: May 15, 2013

Page last updated: August 20, 2015

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