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

NCT01857609 | Completed Phase 1

• 1 other identifier: MPI
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Metformin; Proton pump inhibitor; Drug interaction

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (1)

• 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

Study Arms (3)

Metformin only

EXPERIMENTAL

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

Drug: Metformin

Metformin and Pantoprazole

EXPERIMENTAL

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

Drug: Metformin and Pantoprazole

Metformin and Rabeprazole

EXPERIMENTAL

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

Drug: Metformin and Rabeprazole

Interventions

Metformin DRUG

Also known as: Diabex

Metformin only

Metformin and Pantoprazole DRUG

Also known as: Diabex, Pantoloc

Metformin and Pantoprazole

Metformin and Rabeprazole DRUG

Also known as: Diabex, Pariet

Metformin and Rabeprazole

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Metformin; Pantoprazole; Rabeprazole

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jae-Yong Chung, MD, PhD

  Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 20, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

KR (1)